FASTIDIOUS INOCULUM BROTH
FDA 510(k) clearance K883075 · decided 1988-08-15
Clearance details
- K-number
- K883075
- Device name
- FASTIDIOUS INOCULUM BROTH
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1988-07-13
- Decision date
- 1988-08-15
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- JSD
- Device class
- 1
- Regulation number
- 866.2360
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- West Sacramento, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Baxter Healthcare Corp
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.
| Record | Firm | Date |
|---|---|---|
| CAMPY BROTH (K880107) | Hardy Media | 1988-03-30 |
| SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331 (K873324) | Lakewood Biochemical Co., Inc. | 1987-10-02 |
| BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802 (K873218) | Lakewood Biochemical Co., Inc. | 1987-09-23 |
| ALKALINE PEPTONE WATER (K871640) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-05-13 |
| TODD HEWITT W/CNA (LIM BROTH) (K871447) | Remel Co. | 1987-05-13 |
| T9802 TSB W/6.5% NACL (K870594) | Lakewood Biochemical Co., Inc. | 1987-03-30 |
| APL TRYPTIC SOY BROTH (K853609) | Apl Medical Supplies | 1985-09-12 |
| TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE (K844547) | bioMerieux, Inc. | 1985-01-16 |
| SELECTIVE CULTURE MED. TRICHOMONAS (K841836) | Microline Scientific | 1984-05-14 |
| SELECTIVE CULTURE MEDIUM (K840971) | Chatham Biological | 1984-04-13 |
| SELECTIVE BROTH (K841211) | Smith River Biologicals | 1984-04-05 |
| SF BROTH (K834013) | Micro Media Laboratories | 1983-12-27 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077) | Baxter Healthcare Corp | 2025-11-13 |
| FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076) | Baxter Healthcare Corp | 2025-06-30 |
| Floseal Hemostatic Matrix (P990009/S075) | Baxter Healthcare Corp | 2025-01-30 |
| Adept Adhesion Reduction Solution (P050011/S009) | Baxter Healthcare Corp | 2024-08-23 |
| Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074) | Baxter Healthcare Corp | 2024-08-15 |
| Floseal Hemostatic Matrix (P990009/S073) | Baxter Healthcare Corp | 2024-01-10 |
| Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072) | Baxter Healthcare Corp | 2023-12-12 |
| Floseal Hemostatic Matrix, RT5 (P990009/S070) | Baxter Healthcare Corp | 2023-02-02 |