RPR Liquid Controls
FDA 510(k) K955143 · Remel, L.P.
510(k) numberK955143
Submission
- Device name
- RPR Liquid Controls
- Applicant
- Remel, L.P.
Augusta, GA, US - Received
- November 13, 1995
- Decision date
- July 30, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| 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 |
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| K955136 | RPR Card Test KitGMQ · Traditional | 07/29/1996SE |
| K961819 | Streptomycin Disk (300MCG)JTN · Traditional | 07/10/1996SE |
| K961818 | Gentamicin Disk (120MCG)JTN · Traditional | 07/10/1996SE |
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Questions and answers
When was RPR Liquid Controls cleared by the FDA?
RPR Liquid Controls (K955143) received a 510(k) decision of Substantially Equivalent on July 30, 1996, 260 days after the submission was received.
What is the product code of K955143?
The FDA product code is GMP – Antisera, Control For Nontreponemal Tests, a Class II (moderate risk) device regulated under 21 CFR 866.3820.