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FDA 510(k)

EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95

K-Number: K882766 · 1988-08-23

ApplicantEm Diagnostic Systems, Inc.
Decision Date1988-08-23
Product CodeDLG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95 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 1988-08-23 under 510(k) number K882766. The device is classified under product code DLG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95?

EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95 is a medical device that received FDA 510(k) clearance on 1988-08-23. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K882766.

When did EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95 receive FDA 510(k) clearance?

EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95 received FDA 510(k) clearance on 1988-08-23, under 510(k) number K882766.

Who is the listed applicant for EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95?

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 ACETAMINOPHEN CALIBRATOR NO. 67636/95?

The FDA product code for EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95 is DLG.

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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: DLG)

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.

K050988OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLSLin-Zhi International, Inc.K920419IL TEST DAT CAL/CONTROL SET D/EInstrumentation Laboratory COK894524FPR GENTAMICIN CALIBRATOR KITColony Laboratories, Inc.K894518FPR AMIKACIN CALIBRATOR KITColony Laboratories, Inc.K894528FPR PHENYTOIN CALIBRATOR KITColony Laboratories, Inc.K833385N-ACETYLPROCAINAMIDE CALIBRATORE.I. Dupont DE Nemours & Co., Inc.

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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