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FDA 510(k)

CK-MB IMMUNOASSAY CONTROL

K-Number: K905623 · 1991-02-22

ApplicantSeradyn, Inc.
Decision Date1991-02-22
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CK-MB IMMUNOASSAY CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Seradyn, Inc.. It received FDA 510(k) clearance on 1991-02-22 under 510(k) number K905623. 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 CK-MB IMMUNOASSAY CONTROL?

CK-MB IMMUNOASSAY CONTROL is a medical device that received FDA 510(k) clearance on 1991-02-22. The listed applicant is Seradyn, Inc.. The 510(k) number is K905623.

When did CK-MB IMMUNOASSAY CONTROL receive FDA 510(k) clearance?

CK-MB IMMUNOASSAY CONTROL received FDA 510(k) clearance on 1991-02-22, under 510(k) number K905623.

Who is the listed applicant for CK-MB IMMUNOASSAY CONTROL?

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

What is the FDA product code for CK-MB IMMUNOASSAY CONTROL?

The FDA product code for CK-MB IMMUNOASSAY CONTROL is JJT.

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Other records listing Seradyn, Inc. 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.

K070645SERADYN QMS TOPIRAMATEK062966QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLSK062204ARCHITECT CORTISOL ASSAYK060998QMS TOBRAMYCINK060709MULTIGENT GENTAMICINK052826QMS QUINIDINE. QMS QUINIDINE CALIBRATORS

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Related Devices (Code: JJT)

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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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