Biocheck Ige Elisa, Model BC-1035
FDA 510(k) K992528 · Biocheck, Inc.
510(k) numberK992528
Submission
- Device name
- Biocheck Ige Elisa, Model BC-1035
- Applicant
- Biocheck, Inc.
Northridge, CA, US - Received
- July 28, 1999
- Decision date
- September 21, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DGC – Ige, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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Questions and answers
When was Biocheck Ige Elisa, Model BC-1035 cleared by the FDA?
Biocheck Ige Elisa, Model BC-1035 (K992528) received a 510(k) decision of Substantially Equivalent on September 21, 1999, 55 days after the submission was received.
What is the product code of K992528?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.