FDA 510(k)

IIF-APCA TEST KIT

K-Number: K790759 · 1979-07-30

Decision Date1979-07-30

Product CodeDBJ

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

IIF-APCA TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medica Corp.. It received FDA 510(k) clearance on 1979-07-30 under 510(k) number K790759. The device is classified under product code DBJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IIF-APCA TEST KIT?

IIF-APCA TEST KIT is a medical device that received FDA 510(k) clearance on 1979-07-30. The listed applicant is Medica Corp.. The 510(k) number is K790759.

When did IIF-APCA TEST KIT receive FDA 510(k) clearance?

IIF-APCA TEST KIT received FDA 510(k) clearance on 1979-07-30, under 510(k) number K790759.

Who is the listed applicant for IIF-APCA TEST KIT?

The FDA 510(k) record lists Medica Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IIF-APCA TEST KIT?

The FDA product code for IIF-APCA TEST KIT is DBJ.

Other records listing Medica Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K123802EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT K120497EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL K111363PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL K111005ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL K112788EASTLYTE NA/K/CA/PH K101089EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR

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Related Devices (Code: DBJ)

K930422SYNELISA PARIETAL CELL ANTIBODIESElias U.S.A., Inc.

Official Source

View on FDA Database →

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