Stratus Ck-Mb Dendrimer Fluorometric Enzyme Immunoassay & Stratus Ck-Mb Dendrimer High Sample Diluent
FDA 510(k) K952250 · Dade Intl., Inc.
510(k) numberK952250
Submission
- Device name
- Stratus Ck-Mb Dendrimer Fluorometric Enzyme Immunoassay & Stratus Ck-Mb Dendrimer High Sample Diluent
- Applicant
- Dade Intl., Inc.
Miami, FL, US - Received
- May 15, 1995
- Decision date
- July 17, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JHS – Differential Rate Kinetic Method, Cpk Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1215
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K160570 | Creatine KinaseJHS · Traditional | Roche Diagnostics Operations (Rdo) | 05/25/2016SE |
| K102706 | CKMB Udr AssayJHS · Traditional | SENTINEL CH. SpA | 08/19/2011SE |
| K082226 | S40 Creatine Kinase (CK)JHS · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 09/18/2008SE |
| K062128 | The Dimension Vista Flex Reagent Cartridges / Kit AssaysJHS · Special | Dade Behring, Inc. | 08/21/2006SE |
| K990439 | Careside CKJHS · Traditional | Careside, Inc. | 04/19/1999SE |
| K990434 | Careside CKMBJHS · Traditional | Careside, Inc. | 04/19/1999SE |
| K981495 | Immulite Ck-Mb, Catalog # LKCP1 (100 Tests), LKCP5 (500 Tests)JHS · Traditional | Diagnostic Products Corp. | 06/10/1998SE |
| K962126 | Acs CKMB II ImmunoassayJHS · Traditional | Ciba Corning Diagnostics Corp. | 06/21/1996SE |
| K945083 | Access Ck-Mb ReagentsJHS · Traditional | Bio-Rad Laboratories, Inc. | 11/21/1994SE |
| K943024 | Kinase IsoenzymeJHS · Traditional | Dupont Medical Products | 08/02/1994SE |
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Questions and answers
When was Stratus Ck-Mb Dendrimer Fluorometric Enzyme Immunoassay & Stratus Ck-Mb Dendrimer High Sample Diluent cleared by the FDA?
Stratus Ck-Mb Dendrimer Fluorometric Enzyme Immunoassay & Stratus Ck-Mb Dendrimer High Sample Diluent (K952250) received a 510(k) decision of Substantially Equivalent on July 17, 1995, 63 days after the submission was received.
What is the product code of K952250?
The FDA product code is JHS – Differential Rate Kinetic Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.