Pharmacia Cap System Ige Feia, Model 10-9395-01
FDA 510(k) K991945 · Pharmacia & Upjohn Co.
510(k) numberK991945
Submission
- Device name
- Pharmacia Cap System Ige Feia, Model 10-9395-01
- Applicant
- Pharmacia & Upjohn Co.
Westervillle, OH, US - Received
- June 9, 1999
- Decision date
- July 28, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Pharmacia Cap System Ige Feia, Model 10-9395-01 cleared by the FDA?
Pharmacia Cap System Ige Feia, Model 10-9395-01 (K991945) received a 510(k) decision of Substantially Equivalent on July 28, 1999, 49 days after the submission was received.
What is the product code of K991945?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.