Ultrazyme Plus Ck-I, #64978,65027&65028
FDA 510(k) K821460 · Emd Chemicals, Inc.
510(k) numberK821460
Submission
- Device name
- Ultrazyme Plus Ck-I, #64978,65027&65028
- Applicant
- Emd Chemicals, Inc.
Mchenry, IL, US - Received
- May 18, 1982
- Decision date
- June 1, 1982
- 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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| K062737 | Cardiac Markers on Abx Pentra 400 Clinical Chemistry AnalyzerCGS · Traditional | Horiba Abx | 06/12/2007SE |
| K051648 | Spotchem II Inoganic Phosphorus, CPK and Uric Acid TestsCGS · Traditional | Arkray, Inc. | 01/31/2006SE |
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| K973054 | Ethyl Alcohol Clinical Standard SolutionsDNN · Traditional | 10/01/1997SE |
| K951494 | Amylase Test Item 97381/94 (R1, 97382/94 (R2-SR)CIJ · Traditional | 12/11/1995SE |
| K951750 | Glucose Test Item Number 97375/94LFR · Traditional | 09/06/1995SE |
| K950234 | Total Protein Test (Tpro) Item Number: XXXXX/R1. R2CEK · Traditional | 06/14/1995SE |
| K950128 | Total Protein Test (Tpro) Item XXXXX/R1. R2CEK · Traditional | 05/15/1995SE |
| K945322 | Phosphorus Test (Phos) Item Number 65416CEO · Traditional | 12/07/1994SE |
| K945368 | Phosphorus Test (Phos)CEO · Traditional | 12/02/1994SE |
Questions and answers
When was Ultrazyme Plus Ck-I, #64978,65027&65028 cleared by the FDA?
Ultrazyme Plus Ck-I, #64978,65027&65028 (K821460) received a 510(k) decision of Substantially Equivalent on June 1, 1982, 14 days after the submission was received.
What is the product code of K821460?
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.