VISUWELL REAGIN TEST 960 TEST KIT
FDA 510(k) clearance K885298 · decided 1989-03-15
Clearance details
- K-number
- K885298
- Device name
- VISUWELL REAGIN TEST 960 TEST KIT
- Applicant
- Allelix Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-12-27
- Decision date
- 1989-03-15
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- GMP
- Device class
- 2
- Regulation number
- 866.3820
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Canada L4v 1p1, CA
- 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 |
|---|---|---|
| ADI SYPHILIS RPR LIQUID CONTROLS (K980638) | Ampcor Diagnostics, Inc. | 1998-07-06 |
| QUALITROL SYPHSERO CONTROL SET (K961998) | Consolidated Technologies, Inc. | 1996-08-08 |
| RPR LIQUID CONTROLS (K955143) | Remel, L.P. | 1996-07-30 |
| V-TREND RPRL CARD TEST (K875180) | Texas Immunology, Inc. | 1988-02-04 |
| VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010 (K851504) | Ncs Diagnostics, Inc. | 1985-08-19 |
| RPR TEST REDITEST (K843741) | Biokit USA, Inc. | 1984-10-25 |
| BECKMAN R.PR CONTROL SERUM SET (K812425) | Beckman Instruments, Inc. | 1981-09-23 |
| CONTROL SERUMS FOR NONTREPONEMAL TEST (K810119) | Hillside Acres, Inc. | 1981-02-09 |
Recalls involving this device
No recalls on record reference this clearance.