Visuwell Reagin Test 960 Test Kit
FDA 510(k) K885298 · Allelix Diagnostics, Inc.
510(k) numberK885298
Submission
- Device name
- Visuwell Reagin Test 960 Test Kit
- Applicant
- Allelix Diagnostics, Inc.
Canada L4v 1p1, CA - Received
- December 27, 1988
- Decision date
- March 15, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GMP – Antisera, Control For Nontreponemal Tests
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3820
- Specialty
- Microbiology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K980638 | Adi Syphilis RPR Liquid ControlsGMP · Traditional | Ampcor Diagnostics, Inc. | 07/06/1998SE |
| K961998 | Qualitrol Syphsero Control SetGMP · Traditional | Consolidated Technologies, Inc. | 08/08/1996SE |
| K955143 | RPR Liquid ControlsGMP · Traditional | Remel, L.P. | 07/30/1996SE |
| K875180 | V-Trend RPRL Card TestGMP · Traditional | Texas Immunology, Inc. | 02/04/1988SE |
| K851504 | VDRL Carbon Antigen Test S900500, S900250 & S90010GMP · Traditional | Ncs Diagnostics, Inc. | 08/19/1985SE |
| K843741 | RPR Test ReditestGMP · Traditional | Biokit USA, Inc. | 10/25/1984SE |
| K812425 | Beckman R.Pr Control Serum SetGMP · Traditional | Beckman Instruments, Inc. | 09/23/1981SE |
| K810119 | Control Serums for Nontreponemal TestGMP · Traditional | Hillside Acres, Inc. | 02/09/1981SE |
More from Hillside Acres, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K880665 | Modified Group a Streptococcus Detection KitGTZ · Traditional | 03/01/1988SE |
Questions and answers
When was Visuwell Reagin Test 960 Test Kit cleared by the FDA?
Visuwell Reagin Test 960 Test Kit (K885298) received a 510(k) decision of Substantially Equivalent on March 15, 1989, 78 days after the submission was received.
What is the product code of K885298?
The FDA product code is GMP – Antisera, Control For Nontreponemal Tests, a Class II (moderate risk) device regulated under 21 CFR 866.3820.