Vitros Chemistry Products Upro Slides
FDA 510(k) K964960 · Johnson & Johnson Clinical Diagnostics, Inc.
510(k) numberK964960
Submission
- Device name
- Vitros Chemistry Products Upro Slides
- Applicant
- Johnson & Johnson Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- December 11, 1996
- Decision date
- February 18, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JGP – Lowry (Colorimetric), Total Protein
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1635
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JGP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070757 | Microprotein Reagent SetJGP · Traditional | Pointe Scientific, Inc., | 12/04/2007SE |
| K863112 | ProteinmeterJGP · Traditional | J. D. Assoc. | 12/10/1986SE |
| K821534 | Hematology Data Management SysJGP · Traditional | Biovation, Inc. | 06/10/1982SE |
| K792347 | Micro Lowry ProteintestJGP · Traditional | Panmed, Inc. | 12/06/1979SE |
More from Panmed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K980283 | Vitros Chemistry Products CRBM SlidesKLT · Traditional | 02/25/1998SE |
| K974644 | Vitros Immunodiagnostic Products Range VerifiersJJX · Traditional | 01/13/1998SE |
| K973517 | Vitros Immunodiagnostic Products Range VerifiersJJY · Traditional | 09/25/1997SE |
| K973030 | Vitros Immunodiagnostics Products/Ck-Mb Reagent PACK(GEM.1300)/CK-MB Calibrators…JJY · Traditional | 09/04/1997SE |
| K972133 | Vitros Immunodiagnostics Products Progesterone Reagent Pack (GEM.1070), Progesterone…JLS · Traditional | 06/24/1997SE |
| K970894 | Vitros Immunodiagnostics Products Total B-Hcg Reagent Pack (GEM.1075), Total B-Hcg…DHA · Traditional | 04/14/1997SE |
| K970643 | Vitros Immunodiagnostics Products Estradiol Reagent Pack(Gem. 1050)/ESTRADIOL…CHP · Traditional | 03/18/1997SE |
| K965142 | Vitros Immunodiagnostics Products Free T4 Reagent Pack (GEM.1015) Free T4 Calibrators…CEC · Traditional | 03/18/1997SE |
| K970281 | Vitros Immunodiagnostic Products Prolactin Reagent Pack/CalibratorsCFT · Traditional | 02/25/1997SE |
| K964982 | Vitros Immunodiagnostics Products LH Reagent Pack (GEM.1055) and LH Calibrators (GEM.CO55)CEP · Traditional | 02/20/1997SE |
Questions and answers
When was Vitros Chemistry Products Upro Slides cleared by the FDA?
Vitros Chemistry Products Upro Slides (K964960) received a 510(k) decision of Substantially Equivalent on February 18, 1997, 69 days after the submission was received.
What is the product code of K964960?
The FDA product code is JGP – Lowry (Colorimetric), Total Protein, a Class II (moderate risk) device regulated under 21 CFR 862.1635.