RUBELLA ANTIGEN AND CONTROL ANTIGEN
FDA 510(k) clearance K894262 · decided 1989-10-16
Clearance details
- K-number
- K894262
- Device name
- RUBELLA ANTIGEN AND CONTROL ANTIGEN
- Applicant
- Microbix Biosystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-06-21
- Decision date
- 1989-10-16
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- GON
- Device class
- 2
- Regulation number
- 866.3510
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Flemington, NJ, 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 |
|---|---|---|
| MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST (K880157) | Syva Co. | 1988-02-04 |
| 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.