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FDA 510(k)

TARGET ISOCHECK CONTROL SERUM

K-Number: K821183 · 1982-05-14

ApplicantSmithkline Diagnostics, Inc.
Decision Date1982-05-14
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TARGET ISOCHECK CONTROL SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Smithkline Diagnostics, Inc.. It received FDA 510(k) clearance on 1982-05-14 under 510(k) number K821183. 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 TARGET ISOCHECK CONTROL SERUM?

TARGET ISOCHECK CONTROL SERUM is a medical device that received FDA 510(k) clearance on 1982-05-14. The listed applicant is Smithkline Diagnostics, Inc.. The 510(k) number is K821183.

When did TARGET ISOCHECK CONTROL SERUM receive FDA 510(k) clearance?

TARGET ISOCHECK CONTROL SERUM received FDA 510(k) clearance on 1982-05-14, under 510(k) number K821183.

Who is the listed applicant for TARGET ISOCHECK CONTROL SERUM?

The FDA 510(k) record lists Smithkline Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TARGET ISOCHECK CONTROL SERUM?

The FDA product code for TARGET ISOCHECK CONTROL SERUM is JJT.

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Other records listing Smithkline Diagnostics, Inc. as applicant

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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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