AGGLUTINOTEST-STAPHYLOLISIN
FDA 510(k) clearance K791453 · decided 1979-09-24
Clearance details
- K-number
- K791453
- Device name
- AGGLUTINOTEST-STAPHYLOLISIN
- Applicant
- Volu Sol Medical Industries
- Decision
- Substantially Equivalent
- Date received
- 1979-08-06
- Decision date
- 1979-09-24
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- GTN
- Device class
- 1
- Regulation number
- 866.3700
- 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.
| Record | Firm | Date |
|---|---|---|
| DIAGNOSTIC REAGENT SET-RPLA (K855233) | Oxoid U.S.A., Inc. | 1986-11-04 |
| DIAGNOSTIC REAGENT TST-RPLA (K855236) | Oxoid U.S.A., Inc. | 1986-11-04 |
| STAPHAUREX ZL30 (K851949) | Wellcome Diagnostics | 1985-05-22 |
Recalls involving this device
No recalls on record reference this clearance.