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FDA 510(k)

P.A.P. RIA CONTROL SERUM PACK

K-Number: K790985 · 1979-07-17

ApplicantMallinckrodt Critical Care
Decision Date1979-07-17
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

P.A.P. RIA CONTROL SERUM 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 1979-07-17 under 510(k) number K790985. The device is classified under product code JJT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P.A.P. RIA CONTROL SERUM PACK?

P.A.P. RIA CONTROL SERUM PACK is a medical device that received FDA 510(k) clearance on 1979-07-17. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K790985.

When did P.A.P. RIA CONTROL SERUM PACK receive FDA 510(k) clearance?

P.A.P. RIA CONTROL SERUM PACK received FDA 510(k) clearance on 1979-07-17, under 510(k) number K790985.

Who is the listed applicant for P.A.P. RIA CONTROL SERUM 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 P.A.P. RIA CONTROL SERUM PACK?

The FDA product code for P.A.P. RIA CONTROL SERUM PACK is JJT.

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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.

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Related Devices (Code: JJT)

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.

K090940SPOTCHECK BLOOD SPOT CONTROL, ASSAYEDAstoria-Pacific, Inc.K062751MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKERQuantimetrix Corp.K030768CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVELCliniqa CorporationK030102ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3Bayer Healthcare, LLCK021498LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVELBio-RadK012656LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648Bio-Rad

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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