TRYPTIC SOY BROTH(TSB) W/C02 & 1% YEAST
FDA 510(k) clearance K800426 · decided 1980-03-19
Clearance details
- K-number
- K800426
- Device name
- TRYPTIC SOY BROTH(TSB) W/C02 & 1% YEAST
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1980-02-26
- Decision date
- 1980-03-19
- 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
- Abbott Park, 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.
| Record | Firm | Date |
|---|---|---|
| SPORDEX CULTURE MEDIA (K850143) | American Sterilizer Co. | 1985-03-05 |
| BRAIN HEART INFUSION BROTH (K842852) | Anarobe Systems | 1984-08-03 |
| TRYPTICASE SOY BROTH (K842849) | Anarobe Systems | 1984-08-03 |
| BRAIN HEART INFUSION BROTH (K841221) | Anaerobe Systems | 1984-04-04 |
| SHOPPED MEAT CARBOHYDRATE (K841219) | Anaerobe Systems | 1984-04-04 |
| 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 Laboratories | 1983-03-17 |
| 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
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |