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FDA 510(k)

RIA QUANT C-PEPTIDE KIT

K-Number: K812689 · 1981-10-06

ApplicantMallinckrodt Critical Care
Decision Date1981-10-06
Product CodeJKD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RIA QUANT C-PEPTIDE 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 1981-10-06 under 510(k) number K812689. The device is classified under product code JKD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIA QUANT C-PEPTIDE KIT?

RIA QUANT C-PEPTIDE KIT is a medical device that received FDA 510(k) clearance on 1981-10-06. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K812689.

When did RIA QUANT C-PEPTIDE KIT receive FDA 510(k) clearance?

RIA QUANT C-PEPTIDE KIT received FDA 510(k) clearance on 1981-10-06, under 510(k) number K812689.

Who is the listed applicant for RIA QUANT C-PEPTIDE 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 C-PEPTIDE KIT?

The FDA product code for RIA QUANT C-PEPTIDE KIT is JKD.

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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 MONITORK873461LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)K874404HI-LO TEMP(R) SKIN TEMPERATURE SENSOR

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Related Devices (Code: JKD)

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.

K951848AIA-PACK CPR ASSAYTosoh Medics, Inc.K943767IMMULITE C-PEPTIDEDiagnostic Products Corp.K896420DSL C-PEPTIDE RIA (DSL #7000)Diagnostic Systems Laboratories, Inc.K854066DOUBLE ANTIBODY C-PEPTIDE RIA KITDiagnostic Products Corp.K842267C-PEP-RIA-100Institut National Des RadioelementsK833396C-PEPTIDE RADIOIMMUNOASSAY TEST KITSerono Diagnostics, 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.

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