510(k) K885298
- Device
- VISUWELL REAGIN TEST 960 TEST KIT
- Applicant
- ALLELIX DIAGNOSTICS, INC.
- 510(k) number
- K885298
- Product code
- GMP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-03-15
- Date received
- 1988-12-27
- Regulation
- 866.3820
- Classification name
- Antisera, Control For Nontreponemal Tests
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JANET SHAW
- Address
- 6850 Goreway Dr. Mississauga, Ontario Canada L4v 1p1 CA
FDA Registration Numbers#
- 1641328
- 1119779
- 2029372
- 2242436
- 2250030
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GMP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K980638 | ADI SYPHILIS RPR LIQUID CONTROLS | Ampcor Diagnostics, Inc. | 1998-07-06 |
| K961998 | QUALITROL SYPHSERO CONTROL SET | Consolidated Technologies, Inc. | 1996-08-08 |
| K955143 | RPR LIQUID CONTROLS | Remel, L.P. | 1996-07-30 |
| K875180 | V-TREND RPRL CARD TEST | Texas Immunology, Inc. | 1988-02-04 |
| K851504 | VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010 | Ncs Diagnostics, Inc. | 1985-08-19 |
| K843741 | RPR TEST REDITEST | Biokit USA, Inc. | 1984-10-25 |
| K812425 | BECKMAN R.PR CONTROL SERUM SET | Beckman Instruments, Inc. | 1981-09-23 |
| K810119 | CONTROL SERUMS FOR NONTREPONEMAL TEST | Hillside Acres, Inc. | 1981-02-09 |
Legacy Summary#
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FDA Review#
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