Biocheck Myoglobin Elisa, Model BC-1117
FDA 510(k) K022660 · Biocheck, Inc.
510(k) numberK022660
Submission
- Device name
- Biocheck Myoglobin Elisa, Model BC-1117
- Applicant
- Biocheck, Inc.
Northridge, CA, US - Received
- August 9, 2002
- Decision date
- December 19, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DRR – Amplifier And Signal Conditioner, Biopotential
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2050
- Specialty
- Cardiovascular
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| K002294 | Biocheck Testosterone Eia, Model BC-1115CDZ · Traditional | 10/02/2000SE |
| K001022 | Biocheck, Inc. B-2 Microglobin Enzyme Immunoasay Test Kit, Model BC-1061JZG · Traditional | 09/26/2000SE |
| K992517 | Biocheck Ferritin Elisa Model BC-1025DBF · Traditional | 09/24/1999SE |
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| K991741 | Biocheck HCG Enzyme Immunoassay Test Kit, Model BC-1027JHI · Traditional | 07/22/1999SE |
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Questions and answers
When was Biocheck Myoglobin Elisa, Model BC-1117 cleared by the FDA?
Biocheck Myoglobin Elisa, Model BC-1117 (K022660) received a 510(k) decision of Substantially Equivalent on December 19, 2002, 132 days after the submission was received.
What is the product code of K022660?
The FDA product code is DRR – Amplifier And Signal Conditioner, Biopotential, a Class II (moderate risk) device regulated under 21 CFR 870.2050.