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FDA 510(k)

RIA-QUANT FPA TEST KIT

K-Number: K821151 · 1982-07-22

ApplicantMallinckrodt Critical Care
Decision Date1982-07-22
Product CodeDAN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RIA-QUANT FPA TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1982-07-22 under 510(k) number K821151. The device is classified under product code DAN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIA-QUANT FPA TEST KIT?

RIA-QUANT FPA TEST KIT is a medical device that received FDA 510(k) clearance on 1982-07-22. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K821151.

When did RIA-QUANT FPA TEST KIT receive FDA 510(k) clearance?

RIA-QUANT FPA TEST KIT received FDA 510(k) clearance on 1982-07-22, under 510(k) number K821151.

Who is the listed applicant for RIA-QUANT FPA TEST KIT?

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

What is the FDA product code for RIA-QUANT FPA TEST KIT?

The FDA product code for RIA-QUANT FPA TEST KIT is DAN.

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Other records listing Mallinckrodt Critical Care 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.

K880343BURNEY GALLBLADDER CATHETER KITK874605HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSORK874514HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBEK874568HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITORK874404HI-LO TEMP(R) SKIN TEMPERATURE SENSORK873461LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)

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Related Devices (Code: DAN)

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.

K884496RIA/MAT FPA TEST KITAltana, Inc.K854384ASSERACHROM FPA KITAmerican Bioproducts Co.

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.

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