Who else makes this device?

Name: ACU-Sabouraud
Brand: ACU-Sabouraud

ACU-Sabouraud · Culture Media, Selective and Non-Differential → Immunology & Microbiology

1manufacturer

1catalogue number

3510(k) clearances naming this product code

Who Else Makes It

Registered in Shandong.

Chinese manufacturers registered for FDA product code JSJ
Manufacturer	City	Province	Registered as	Device types
Jinan Babio Biotechnology Co., Ltd.	Jinan	Shandong	Manufacturer	25

Record

Regulatory record for ACU-Sabouraud
Listed by	Acuderm, Inc., United States
FDA product code	JSJ
Device type	Culture Media, Selective And Non-Differential
Device class	Class 1
Regulation	21 CFR 866.2360
Establishment	Repacker / relabeller, Manufacturer
510(k)	K832583
Record published	2020-09-22

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes

Catalogue Numbers

Catalogue numbers for ACU-Sabouraud
Catalogue number	Size	Per pack	Status
M103		24	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Remel	Remel, Inc.	132
Culture Media, Selective And Non-Differential	Hardy Diagnostics	85
Edge Biologicals Inc	Edge Biologicals, Inc.	17
HardyFlask™	Hardy Diagnostics	12
Alpha-Tec Systems	Alpha-Tec Systems, Inc.	11
Redipor	Analytichem USA, Inc.	9
AnaeroGRO	Hardy Diagnostics	3
BD BBL™ Campylobacter Agar with 5 Antimicrobics and 10% Sheep Blood	Becton, Dickinson AND Company	2
BD BBL™ XLD Agar	Becton, Dickinson AND Company	2
BD BBL™ Selenite-F Broth	Becton, Dickinson AND Company	2
BD BBL™ Campy CVA Agar	Becton, Dickinson AND Company	2
BD BBL™ Mycosel™ Agar Slants	Becton, Dickinson AND Company	2

Showing 12 of 92. All products under Culture Media, Selective And Non-Differential

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K832581	1983-09-12
K832583	1983-09-12
K832582	1983-09-12

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.

ACU-Sabouraud