RPR Test Reditest
FDA 510(k) K843741 · Biokit USA, Inc.
510(k) numberK843741
Submission
- Device name
- RPR Test Reditest
- Applicant
- Biokit USA, Inc.
Barcelona, Spain, US - Received
- September 25, 1984
- Decision date
- October 25, 1984
- 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
Other 510(k)s with product code GMP
| 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 |
| K885298 | Visuwell Reagin Test 960 Test KitGMP · Traditional | Allelix Diagnostics, Inc. | 03/15/1989SE |
| 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 |
| 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 |
|---|---|---|
| K913467 | ToxogenLLA · Traditional | 01/11/1993SE |
| K910541 | Biokit RPRGMQ · Traditional | 10/18/1991SE |
| K904310 | Rheumagen RF T-ControlDHR · Traditional | 05/31/1991SE |
| K910539 | Rheumajet RFDHR · Traditional | 04/05/1991SE |
| K910686 | Rheumajet CRPDCN · Traditional | 03/19/1991SE |
| K904311 | Rheumagen Aso T-ControlGTQ · Traditional | 01/25/1991SE |
| K904312 | Rheumagen CRP T-ControlDCK · Traditional | 10/01/1990SE |
| K896433 | Modified RubagenLQN · Traditional | 11/29/1989SE |
| K896272 | Quantex CRP Plus (Latex, Buffer, Standard, ControlDCN · Traditional | 11/08/1989SE |
| K896271 | Quantex RF Plus (Latex, Buffer Standard, Control)DHR · Traditional | 11/08/1989SE |
Questions and answers
When was RPR Test Reditest cleared by the FDA?
RPR Test Reditest (K843741) received a 510(k) decision of Substantially Equivalent on October 25, 1984, 30 days after the submission was received.
What is the product code of K843741?
The FDA product code is GMP – Antisera, Control For Nontreponemal Tests, a Class II (moderate risk) device regulated under 21 CFR 866.3820.