Who else makes this device?

Name: K-Assay® ASO/RF/CRP Control
Brand: K-Assay® ASO/RF/CRP Control

Clinical Chemistry › Test SystemsMulti-Analyte Controls, All Kinds (Assayed)

K-Assay® ASO/RF/CRP Control

2 catalogue numbers from K55C-4M, listed by Kamiya Biomedical Company LLC, United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

2catalogue numbers in this listing

2510(k) clearances naming this product code

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code JJY
Manufacturer	City	Province	Registered as	Device types
Getein Biotech, Inc.	Nanjing	Jiangsu	Manufacturer	19

Record

Regulatory record for K-Assay® ASO/RF/CRP Control
Listed by	Kamiya Biomedical Company LLC, United States
FDA product code	JJY
Device type	Multi-Analyte Controls, All Kinds (Assayed)
Device class	Class 1
Regulation	21 CFR 862.1660
Establishment	Repacker / relabeller, Manufacturer
510(k)	K983241
Record published	2016-09-16
Record revised	2022-08-17 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C
Distribution end date	2022-08-16

Catalogue Numbers

Catalogue numbers for K-Assay® ASO/RF/CRP Control
Catalogue number	Size	Status
K55C-4M		In distribution
K55C-2M		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Liquichek	Bio-Rad Laboratories Inc.	154
Validate	LGC Clinical Diagnostics, Inc.	120
InteliQ	Bio-Rad Laboratories Inc.	50
Lyphochek	Bio-Rad Laboratories Inc.	39
Stat Profile	Nova Biomedical Corporation	38
i-STAT	Abbott Point OF Care Inc.	24
Multichem AE	Techno-Path Manufacturing Ltd.	20
Serum Control	Chromsystems Instruments & Chemicals Gmbh	18
BioPlex 2200	Bio-Rad Laboratories Inc.	16
Nova	Nova Biomedical Corporation	14
Plasma Control	Chromsystems Instruments & Chemicals Gmbh	14
Multichem IA Speciality	Techno-Path Manufacturing Ltd.	12

Showing 12 of 559. All products under Multi-Analyte Controls, All Kinds (Assayed)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K983241	1998-09-29
K983130	1998-09-29

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.