MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST
FDA 510(k) clearance K880157 · decided 1988-02-04
Clearance details
- K-number
- K880157
- Device name
- MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1988-01-13
- Decision date
- 1988-02-04
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- GON
- Device class
- 2
- Regulation number
- 866.3510
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Palo Alto, 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 |
|---|---|---|
| RUBELLA ANTIGEN AND CONTROL ANTIGEN (K894262) | Microbix Biosystems, Inc. | 1989-10-16 |
| HERPES SIMPLEX TYPE I (K802939) | Orion Diagnostica, Inc. | 1980-12-31 |
| RUBELLA VIRUS ANTIGENS & CONTROLS (K802937) | Orion Diagnostica, Inc. | 1980-12-31 |
| RUBELISA TEST KIT (K780996) | Microbiological Assoc. | 1978-11-22 |
Recalls involving this device
No recalls on record reference this clearance.