Virgo(R) Microwell Alt Assay
FDA 510(k) K884784 · Electro-Nucleonics, Inc.
510(k) numberK884784
Submission
- Device name
- Virgo(R) Microwell Alt Assay
- Applicant
- Electro-Nucleonics, Inc.
Columbia, MD, US - Received
- November 15, 1988
- Decision date
- December 29, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CKD – Hydrazone Colorimetry, Alt/Sgpt
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1030
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CKD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K991834 | Cholestech LDX Alanine Aminotransferase (Alt), Model 11-772CKD · Traditional | Cholestech Corp. | 09/09/1999SE |
| K941192 | Ortho Alt Microwell Test SystemCKD · Traditional | Ortho Diagnostic Systems, Inc. | 05/16/1995SE |
| K896237 | Cobas Ready Alt ReagentCKD · Traditional | Roche Diagnostic Systems, Inc. | 02/16/1990SE |
| K883387 | Alanine Amino Transferase (Colorimetric Method)CKD · Traditional | Tech-Co, Inc. | 10/13/1988SE |
| K864082 | Reflotron(R) Alt (GPT)CKD · Traditional | Boehringer Mannheim Corp. | 12/04/1986SE |
| K860485 | SGPT (Alt) Reagent Set (Colorimetric)CKD · Traditional | Sterling Diagnostics, Inc. | 04/03/1986SE |
| K844283 | SGPT Reagent SetCKD · Traditional | Livonia Diagnostics, Inc. | 11/27/1984SE |
| K841059 | SGPT Reagent SetCKD · Traditional | Medical Specialties, Inc. | 05/01/1984SE |
| K821207 | SGPT Reagent SetCKD · Traditional | Omega Medical Electronics | 07/14/1982SE |
| K820491 | SGPT Reagent SetCKD · Traditional | Anco Medical Reagents & Assoc. | 03/11/1982SE |
More from Anco Medical Reagents & Assoc.
| 510(k) | Device | Decision |
|---|---|---|
| K893718 | Deltatest (R) Lipase IICET · Traditional | 09/28/1989SE |
| K883670 | Serological Test Kit for Igg Anti. Epstein-Barr ViGNP · Traditional | 04/28/1989SE |
| K883427 | Virgo(R) Vzv-Igg ElisaGQX · Traditional | 03/10/1989SE |
| K883282 | Virgo HSV-1 Igg ElisaGQO · Traditional | 03/10/1989SE |
| K883281 | Virgo HSV-2 Igg ElisaGQO · Traditional | 03/10/1989SE |
| K883102 | Virgo (R) Cmv-Igg ElisaGQI · Traditional | 02/08/1989SE |
| K883206 | Lactate Dehydrogenase LDHCFJ · Traditional | 09/09/1988SE |
| K883205 | Altlts Alanine Amino Transferase AltCKA · Traditional | 09/09/1988SE |
Questions and answers
When was Virgo(R) Microwell Alt Assay cleared by the FDA?
Virgo(R) Microwell Alt Assay (K884784) received a 510(k) decision of Substantially Equivalent on December 29, 1988, 44 days after the submission was received.
What is the product code of K884784?
The FDA product code is CKD – Hydrazone Colorimetry, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.