MS-2 BACTERIAL IDENTI. SYS
FDA 510(k) clearance K830099 · decided 1983-02-15
Clearance details
- K-number
- K830099
- Device name
- MS-2 BACTERIAL IDENTI. SYS
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1983-01-11
- Decision date
- 1983-02-15
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- JTO
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT (K050352) | Ameritek Research, LLC | 2005-09-01 |
| PYR SWAB (K970832) | Remel, Inc. | 1997-04-24 |
| GRAM SWAB (K970834) | Remel, Inc. | 1997-04-17 |
| INDOLE SWAB (K970833) | Remel, Inc. | 1997-04-02 |
| LYFO(TM) DIFFERENTIAL DISK-BACITRACIN (K970009) | Microbiologics, Inc. | 1997-02-06 |
| IDS RAPID CB PLUS SYSTEM (K962966) | Innovative Diagnostic Systems, Inc. | 1996-10-08 |
| COLISCREEN (K961191) | Hardy Diagnostics | 1996-06-17 |
| M. CAT BUTYRATE DISK (K960996) | Hardy Diagnostics | 1996-04-18 |
| GIBSON ID-M. CAT. (K955826) | Gibson Laboratories, Inc. | 1996-02-29 |
| DRYSLIDE CARTARRHALIS (K954783) | Difco Laboratories, Inc. | 1996-02-06 |
| LYFO(TM) DIFFERIENTAL DISK-PYR (K954812) | Microbiologics, Inc. | 1995-12-20 |
| GIBSON ID A.E. TEST (K953247) | Gibson Laboratories, Inc. | 1995-11-20 |
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 |