VDRL Carbon Antigen Test S900500, S900250 & S90010
FDA 510(k) K851504 · Ncs Diagnostics, Inc.
510(k) numberK851504
Submission
- Device name
- VDRL Carbon Antigen Test S900500, S900250 & S90010
- Applicant
- Ncs Diagnostics, Inc.
Mississauga, Ontario, CA - Received
- April 15, 1985
- Decision date
- August 19, 1985
- 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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| 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 |
| 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.
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| K882811 | StrepslideGTY · Traditional | 10/25/1988SE |
| K881209 | Aso Slide TestGTQ · Traditional | 04/12/1988SE |
| K874019 | StaphslideJWX · Traditional | 10/28/1987SE |
| K871404 | KultsureJSM · Traditional | 04/21/1987SE |
| K870231 | KultsureLIO · Traditional | 02/04/1987SE |
| K860178 | Kultsure (Culture Transport)JSM · Traditional | 04/04/1986SE |
| K860655 | Kultsure (Catalogue No. M200)LIO · Traditional | 03/06/1986SE |
| K860658 | Kultsure (Catalogue No. M250)JSM · Traditional | 03/04/1986SE |
Questions and answers
When was VDRL Carbon Antigen Test S900500, S900250 & S90010 cleared by the FDA?
VDRL Carbon Antigen Test S900500, S900250 & S90010 (K851504) received a 510(k) decision of Substantially Equivalent on August 19, 1985, 126 days after the submission was received.
What is the product code of K851504?
The FDA product code is GMP – Antisera, Control For Nontreponemal Tests, a Class II (moderate risk) device regulated under 21 CFR 866.3820.