Control Serums for Nontreponemal Test
FDA 510(k) K810119 · Hillside Acres, Inc.
510(k) numberK810119
Submission
- Device name
- Control Serums for Nontreponemal Test
- Applicant
- Hillside Acres, Inc.
Mchenry, IL, US - Received
- January 16, 1981
- Decision date
- February 9, 1981
- 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 |
| 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 |
Questions and answers
When was Control Serums for Nontreponemal Test cleared by the FDA?
Control Serums for Nontreponemal Test (K810119) received a 510(k) decision of Substantially Equivalent on February 9, 1981, 24 days after the submission was received.
What is the product code of K810119?
The FDA product code is GMP – Antisera, Control For Nontreponemal Tests, a Class II (moderate risk) device regulated under 21 CFR 866.3820.