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FDA 510(k)

EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95

K-Number: K862704 · 1986-08-19

ApplicantEm Diagnostic Systems, Inc.
Decision Date1986-08-19
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95 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 1986-08-19 under 510(k) number K862704. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95?

EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95 is a medical device that received FDA 510(k) clearance on 1986-08-19. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K862704.

When did EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95 receive FDA 510(k) clearance?

EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95 received FDA 510(k) clearance on 1986-08-19, under 510(k) number K862704.

Who is the listed applicant for EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95?

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(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95?

The FDA product code for EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95 is JIS.

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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: JIS)

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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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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