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FDA 510(k)

C-PEPTIDE CONTROL PACK

K-Number: K812690 · 1981-10-06

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

Device Summary

C-PEPTIDE CONTROL PACK 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 K812690. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C-PEPTIDE CONTROL PACK?

C-PEPTIDE CONTROL PACK 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 K812690.

When did C-PEPTIDE CONTROL PACK receive FDA 510(k) clearance?

C-PEPTIDE CONTROL PACK received FDA 510(k) clearance on 1981-10-06, under 510(k) number K812690.

Who is the listed applicant for C-PEPTIDE CONTROL PACK?

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 C-PEPTIDE CONTROL PACK?

The FDA product code for C-PEPTIDE CONTROL PACK is JJX.

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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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