HERPES EIA TEST KIT
FDA 510(k) clearance K791397 · decided 1979-09-24
Clearance details
- K-number
- K791397
- Device name
- HERPES EIA TEST KIT
- Applicant
- Microbiological Assoc.
- Decision
- Substantially Equivalent
- Date received
- 1979-07-27
- Decision date
- 1979-09-24
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- GQM
- Device class
- 2
- Regulation number
- 866.3305
- 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 |
|---|---|---|
| COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV (K875367) | Enzo Biochem, Inc. | 1988-03-28 |
| GOAT ANTI-HERPES SIMPLEX VIRUS TYPE I (K810043) | Vibac Corp. | 1981-05-15 |
Recalls involving this device
No recalls on record reference this clearance.