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FDA 510(k)

IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R

K-Number: K930166 · 1993-04-21

ApplicantEm Diagnostic Systems, Inc.
Decision Date1993-04-21
Product CodeJIY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R 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 1993-04-21 under 510(k) number K930166. The device is classified under product code JIY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R?

IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R is a medical device that received FDA 510(k) clearance on 1993-04-21. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K930166.

When did IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R receive FDA 510(k) clearance?

IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R received FDA 510(k) clearance on 1993-04-21, under 510(k) number K930166.

Who is the listed applicant for IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R?

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 IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R?

The FDA product code for IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R is JIY.

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: JIY)

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.

K061793DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATORDade Behring, Inc.K060264DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)Dade Behring, Inc.K051115SENTINEL IRON LIQUIDSentinel Ch. SrlK033983VITALAB IRON REAGENTClinical Data, Inc.K030528ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)Clinical DataK020816IRON-PC-SL ASSAY MODEL # 151-10, 151-26Diagnostic Chemicals , Ltd.

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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