GOAT ANTI-HERPES SIMPLEX VIRUS TYPE I
FDA 510(k) clearance K810043 · decided 1981-05-15
Clearance details
- K-number
- K810043
- Device name
- GOAT ANTI-HERPES SIMPLEX VIRUS TYPE I
- Applicant
- Vibac Corp.
- Decision
- Substantially Equivalent
- Date received
- 1981-01-07
- Decision date
- 1981-05-15
- Days to decision
- 128 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 |
| HERPES EIA TEST KIT (K791397) | Microbiological Assoc. | 1979-09-24 |
Recalls involving this device
No recalls on record reference this clearance.