SNAP CAMPYLOBACTOR DIAGNOSTIC KIT
FDA 510(k) clearance K873670 · decided 1988-06-08
Clearance details
- K-number
- K873670
- Device name
- SNAP CAMPYLOBACTOR DIAGNOSTIC KIT
- Applicant
- Molecular Biosystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-09-11
- Decision date
- 1988-06-08
- Days to decision
- 271 days
- Clearance type
- Traditional
- Product code
- LQO
- Device class
- 1
- Regulation number
- 866.3110
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Diego, CA, 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 |
|---|---|---|
| ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION (K894712) | Gen-Probe, Inc. | 1989-11-14 |
| VIROGEN CMV ANTIBODY TEST (K875101) | Wampole Laboratories | 1988-03-01 |
| GENE-TRAK CAMPYLOBACTER ASSAY (K863270) | Integrated Genetics | 1987-08-31 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ALBUNEX(R) ALBUMIN (HUMAN) 5%, SONICATED (P900059/S004) | Molecular Biosystems, Inc. | 1997-06-17 |
| ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES (P900059/S002) | Molecular Biosystems, Inc. | 1996-03-01 |
| ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES (P900059/S003) | Molecular Biosystems, Inc. | 1995-08-28 |
| ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES (P900059/S001) | Molecular Biosystems, Inc. | 1995-07-31 |