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FDA 510(k)

SERUM IRON

K-Number: K771838 · 1977-11-03

ApplicantGamma Enterprises, Inc.
Decision Date1977-11-03
Product CodeJIY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERUM IRON is the device name listed in this FDA 510(k) record. The listed applicant is Gamma Enterprises, Inc.. It received FDA 510(k) clearance on 1977-11-03 under 510(k) number K771838. 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 SERUM IRON?

SERUM IRON is a medical device that received FDA 510(k) clearance on 1977-11-03. The listed applicant is Gamma Enterprises, Inc.. The 510(k) number is K771838.

When did SERUM IRON receive FDA 510(k) clearance?

SERUM IRON received FDA 510(k) clearance on 1977-11-03, under 510(k) number K771838.

Who is the listed applicant for SERUM IRON?

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

What is the FDA product code for SERUM IRON?

The FDA product code for SERUM IRON is JIY.

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Other records listing Gamma Enterprises, 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.

K790578GAMMA SMAC REAGENTSK780506CARBON DIOXIDE REAGENTSK780507SERUM GLUTAMIC-PYRUVIC TRANSAMINASEK780505SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASEK780504CREATINE PHOSPHOKINASE (CPK)K771836LACTATE DEHYDROGENASE

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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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