Vitros Immunodiagnostics Products/Ck-Mb Reagent PACK(GEM.1300)/CK-MB Calibrators (GEM.C300)
FDA 510(k) K973030 · Johnson & Johnson Clinical Diagnostics, Inc.
510(k) numberK973030
Submission
- Device name
- Vitros Immunodiagnostics Products/Ck-Mb Reagent PACK(GEM.1300)/CK-MB Calibrators (GEM.C300)
- Applicant
- Johnson & Johnson Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- August 14, 1997
- Decision date
- September 4, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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More from Aalto Scientific, Ltd.
| 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 |
| 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 |
| K964960 | Vitros Chemistry Products Upro SlidesJGP · Traditional | 02/18/1997SE |
Questions and answers
When was Vitros Immunodiagnostics Products/Ck-Mb Reagent PACK(GEM.1300)/CK-MB Calibrators (GEM.C300) cleared by the FDA?
Vitros Immunodiagnostics Products/Ck-Mb Reagent PACK(GEM.1300)/CK-MB Calibrators (GEM.C300) (K973030) received a 510(k) decision of Substantially Equivalent on September 4, 1997, 21 days after the submission was received.
What is the product code of K973030?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.