FDA 510(k)

KALLESTEAD TOTAL IGE MICROPLATE KIT

K-Number: K912800 · 1991-07-25

Decision Date1991-07-25

Product CodeDGC

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

KALLESTEAD TOTAL IGE MICROPLATE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories, Inc.. It received FDA 510(k) clearance on 1991-07-25 under 510(k) number K912800. 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 KALLESTEAD TOTAL IGE MICROPLATE KIT?

KALLESTEAD TOTAL IGE MICROPLATE KIT is a medical device that received FDA 510(k) clearance on 1991-07-25. The listed applicant is Bio-Rad Laboratories, Inc.. The 510(k) number is K912800.

When did KALLESTEAD TOTAL IGE MICROPLATE KIT receive FDA 510(k) clearance?

KALLESTEAD TOTAL IGE MICROPLATE KIT received FDA 510(k) clearance on 1991-07-25, under 510(k) number K912800.

Who is the listed applicant for KALLESTEAD TOTAL IGE MICROPLATE KIT?

The FDA 510(k) record lists Bio-Rad Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KALLESTEAD TOTAL IGE MICROPLATE KIT?

The FDA product code for KALLESTEAD TOTAL IGE MICROPLATE KIT is DGC.

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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.