Shot-Gun Isolat Proced/Measurement Ck-Mb in Serum
FDA 510(k) K874284 · Diagnostic Chemicals, Ltd. (Usa)
510(k) numberK874284
Submission
- Device name
- Shot-Gun Isolat Proced/Measurement Ck-Mb in Serum
- Applicant
- Diagnostic Chemicals, Ltd. (Usa)
Monroe, CT, US - Received
- October 14, 1987
- Decision date
- January 21, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JHT – Chromatographic Separation, Cpk Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1215
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JHT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022409 | Spectral's Cardiac Status Ck-Mb Rapid TestJHT · Traditional | Spectral Diagnostics, Inc. | 09/30/2002SE |
| K991299 | Modification to Cardiac Status Ck-Mb/Myoglobin Rapid One-Step Test, Lifesign Mi…JHT · Traditional | Princeton BioMeditech Corp. | 05/28/1999SE |
| K930359 | Cardio Rep-Cat. No. 1400 & CK Isoforms Kit 3305JHT · Traditional | Helena Laboratories | 04/12/1993SE |
| K904866 | Coulter Ck-Mb Isoenzyme ReagentJHT · Traditional | Coulter Electronics, Inc. | 12/13/1990SE |
| K904721 | DSL Ck-Mb (DSL #3200)JHT · Traditional | Diagnostic Systems Laboratories, Inc. | 12/13/1990SE |
| K901450 | Modified Label for Embria-Ck, Quick-Mb/Micromi-MbJHT · Traditional | Intl. Immunoassay Laboratories, Inc. | 05/15/1990SE |
| K896170 | Rep CK Isoforms Kit Cat. No. 3081, 3082, 3083JHT · Traditional | Helena Laboratories | 02/16/1990SE |
| K881168 | Creatine Kinase (CK) Isoenzyme MBJHT · Traditional | Data Medical Associates, Inc. | 11/10/1988SE |
| K872041 | Coulter Dart Ck-Mb Isoenzyme Reagent SystemJHT · Traditional | Coulter Electronics, Inc. | 09/16/1987SE |
| K872598 | Micromi-Ck(Tm)JHT · Traditional | Intl. Immunoassay Laboratories, Inc. | 08/03/1987SE |
More from Intl. Immunoassay Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K022538 | Immunodip Urinary Albumin Screen Assay, Catalogue Number 790-25JIR · Special | 08/23/2002SE |
| K974874 | Bilirubin-Sl (Total) AssayCIG · Traditional | 02/12/1998SE |
| K932556 | Ammonia Assay Cat. No. 200-02JIF · Traditional | 08/02/1994SE |
| K932766 | Hdl-Cholestral(Dextran Sulfate/Magnesium)LBR · Traditional | 12/10/1993SE |
| K932555 | Dc-Lineate Cat. No. SE-091JIS · Traditional | 08/19/1993SE |
| K925877 | Dc-Uibc-CalJIS · Traditional | 03/18/1993SE |
| K912825 | Magnesium Assay Kit, Cat.# 100-12JGJ · Traditional | 07/26/1991SE |
| K895964 | DCL Syphilis-M Catalog No. 600-80LIP · Traditional | 01/08/1991SE |
| K895965 | DCL - Syphilis-G Assay Catalog No. 600-70LIP · Traditional | 12/26/1990SE |
| K904660 | Enzymatic Bilirubin (Total), Catalogue No. 202-14JFM · Traditional | 11/20/1990SE |
Questions and answers
When was Shot-Gun Isolat Proced/Measurement Ck-Mb in Serum cleared by the FDA?
Shot-Gun Isolat Proced/Measurement Ck-Mb in Serum (K874284) received a 510(k) decision of Substantially Equivalent on January 21, 1988, 99 days after the submission was received.
What is the product code of K874284?
The FDA product code is JHT – Chromatographic Separation, Cpk Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.