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FDA 510(k)

SYSTE MATE IRON, HEM NO. 67224

K-Number: K845020 · 1985-01-28

ApplicantEm Diagnostic Systems, Inc.
Decision Date1985-01-28
Product CodeJIY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYSTE MATE IRON, HEM NO. 67224 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 1985-01-28 under 510(k) number K845020. 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 SYSTE MATE IRON, HEM NO. 67224?

SYSTE MATE IRON, HEM NO. 67224 is a medical device that received FDA 510(k) clearance on 1985-01-28. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K845020.

When did SYSTE MATE IRON, HEM NO. 67224 receive FDA 510(k) clearance?

SYSTE MATE IRON, HEM NO. 67224 received FDA 510(k) clearance on 1985-01-28, under 510(k) number K845020.

Who is the listed applicant for SYSTE MATE IRON, HEM NO. 67224?

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 SYSTE MATE IRON, HEM NO. 67224?

The FDA product code for SYSTE MATE IRON, HEM NO. 67224 is JIY.

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Other records listing Em Diagnostic Systems, Inc. as applicant

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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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