Cobas(R) Core Ige Total Eia
FDA 510(k) K930890 · Roche Diagnostic Systems, Inc.
510(k) numberK930890
Submission
- Device name
- Cobas(R) Core Ige Total Eia
- Applicant
- Roche Diagnostic Systems, Inc.
Branchburg, NJ, US - Received
- February 22, 1993
- Decision date
- August 5, 1993
- 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 Cobas(R) Core Ige Total Eia cleared by the FDA?
Cobas(R) Core Ige Total Eia (K930890) received a 510(k) decision of Substantially Equivalent on August 5, 1993, 164 days after the submission was received.
What is the product code of K930890?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.