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FDA 510(k)

SERUM IRON REAGENT SET

K-Number: K812840 · 1981-12-03

ApplicantAnco Medical Reagents & Assoc.
Decision Date1981-12-03
Product CodeJIY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERUM IRON REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Anco Medical Reagents & Assoc.. It received FDA 510(k) clearance on 1981-12-03 under 510(k) number K812840. 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 REAGENT SET?

SERUM IRON REAGENT SET is a medical device that received FDA 510(k) clearance on 1981-12-03. The listed applicant is Anco Medical Reagents & Assoc.. The 510(k) number is K812840.

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

SERUM IRON REAGENT SET received FDA 510(k) clearance on 1981-12-03, under 510(k) number K812840.

Who is the listed applicant for SERUM IRON REAGENT SET?

The FDA 510(k) record lists Anco Medical Reagents & Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERUM IRON REAGENT SET?

The FDA product code for SERUM IRON REAGENT SET is JIY.

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Other records listing Anco Medical Reagents & Assoc. 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.

K842440SICKLE CELL STAT A/S HETEROZYGOUS-ERYTHK831871SICKLE-HEME A/S CONTROLS & A/A CONTROLK821658HEMOGLOBIN REAGENTK821526ACID PHOSPHATASE REAGENT SETK821102MEGNESIUM REAGENT KITK820951ENZYMATIC CHOLESTEROL KIT

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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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