Atlas FDA

BRUCELLA BROTH W/SPS, 6% SORBITOL & CO2

FDA 510(k) clearance K790687 · decided 1979-05-03

Clearance details

K-number
K790687
Device name
BRUCELLA BROTH W/SPS, 6% SORBITOL & CO2
Applicant
Gibco Laboratories Life Technologies, Inc.
Decision
Substantially Equivalent
Date received
1979-04-10
Decision date
1979-05-03
Days to decision
23 days
Clearance type
Traditional
Product code
JSC
Device class
1
Regulation number
866.2350
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Gibco Laboratories Life Technologies

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
SPORDEX CULTURE MEDIA (K850143)American Sterilizer Co.1985-03-05
BRAIN HEART INFUSION BROTH (K842852)Anarobe Systems1984-08-03
TRYPTICASE SOY BROTH (K842849)Anarobe Systems1984-08-03
BRAIN HEART INFUSION BROTH (K841221)Anaerobe Systems1984-04-04
SHOPPED MEAT CARBOHYDRATE (K841219)Anaerobe Systems1984-04-04
SABOURAUD BHI AGAR (K833300)Acumedia Manufacturers, Inc.1983-11-07
TRYPTIC SOY BROTH MEDIA (K832620)Carroll Biological Corp.1983-09-12
INFUSION BROTH (K832569)Acumedia Manufacturers, Inc.1983-09-12
EXTRACT BROTH (K832570)Acumedia Manufacturers, Inc.1983-09-12
THIOGLYCOLLATE MEDIUM (K832619)Carroll Biological Corp.1983-09-12
CHS (K830437)Dms Laboratories1983-03-17
WILKINS-CHALGREN ANAEROBE BROTH (K822665)Oxoid U.S.A., Inc.1982-09-21

Recalls involving this device

RecordFirmDate
1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450 recall (Z-0585-2026)Remel, Inc2025-11-21