Atlas FDA

TRYPTICASE SOY BROTH BLOOD CULTURE BOTT

FDA 510(k) clearance K812335 · decided 1981-09-09

Clearance details

K-number
K812335
Device name
TRYPTICASE SOY BROTH BLOOD CULTURE BOTT
Applicant
Fisher Scientific Co., LLC
Decision
Substantially Equivalent
Date received
1981-08-18
Decision date
1981-09-09
Days to decision
22 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

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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

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
FLUORESCENT GONORRHEA TEST-HEATED (FGT-H) (P770001)Fisher Scientific Co., LLC1979-07-18