Ck-Nac 2-VIAL Reagent W/Substrate Start
FDA 510(k) K891470 · Trace Scientific , Ltd.
510(k) numberK891470
Submission
- Device name
- Ck-Nac 2-VIAL Reagent W/Substrate Start
- Applicant
- Trace Scientific , Ltd.
Clayton, Vic 3168, AU - Received
- March 15, 1989
- Decision date
- May 9, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CGS – Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1215
- Specialty
- Clinical Chemistry
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| K932713 | Trace Transferrin ReagentDDQ · Traditional | 09/30/1993SE |
| K923322 | Trace Albumin-Mr ReagentCIX · Traditional | 09/11/1992SE |
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Questions and answers
When was Ck-Nac 2-VIAL Reagent W/Substrate Start cleared by the FDA?
Ck-Nac 2-VIAL Reagent W/Substrate Start (K891470) received a 510(k) decision of Substantially Equivalent on May 9, 1989, 55 days after the submission was received.
What is the product code of K891470?
The FDA product code is CGS – Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.