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FDA 510(k)

EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95

K-Number: K861512 · 1986-05-23

ApplicantEm Diagnostic Systems, Inc.
Decision Date1986-05-23
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95 is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1986-05-23 under 510(k) number K861512. 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 EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95?

EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95 is a medical device that received FDA 510(k) clearance on 1986-05-23. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K861512.

When did EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95 receive FDA 510(k) clearance?

EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95 received FDA 510(k) clearance on 1986-05-23, under 510(k) number K861512.

Who is the listed applicant for EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95?

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

What is the FDA product code for EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95?

The FDA product code for EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95 is JJT.

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Other records listing Em Diagnostic Systems, 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.

K935181ASPARTATE AMINOTRANSFERASE (AST) TESTK935180ALANINE AMINOTRANSFERASE (ALT) TESTK935178EMDS PHOSPHOROUS (PHOS) TESTK935179EMDS ALBUMIN (ALB) TESTK935175LACTATE DEHYDROGENASE (LD)K935174TOTAL PROTEIN TEST (TPRO)

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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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