FDA 510(k)

PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01

K-Number: K991945 · 1999-07-28

Decision Date1999-07-28

Product CodeDGC

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia & Upjohn Co.. It received FDA 510(k) clearance on 1999-07-28 under 510(k) number K991945. The device is classified under product code DGC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01?

PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 is a medical device that received FDA 510(k) clearance on 1999-07-28. The listed applicant is Pharmacia & Upjohn Co.. The 510(k) number is K991945.

When did PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 receive FDA 510(k) clearance?

PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 received FDA 510(k) clearance on 1999-07-28, under 510(k) number K991945.

Who is the listed applicant for PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01?

The FDA 510(k) record lists Pharmacia & Upjohn Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01?

The FDA product code for PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 is DGC.

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Other records listing Pharmacia & Upjohn Co. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.