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FDA 510(k)

IRON REAGENT

K-Number: K891155 · 1989-04-18

ApplicantMedical Analysis Systems, Inc.
Decision Date1989-04-18
Product CodeCFM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IRON REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Medical Analysis Systems, Inc.. It received FDA 510(k) clearance on 1989-04-18 under 510(k) number K891155. The device is classified under product code CFM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRON REAGENT?

IRON REAGENT is a medical device that received FDA 510(k) clearance on 1989-04-18. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K891155.

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

IRON REAGENT received FDA 510(k) clearance on 1989-04-18, under 510(k) number K891155.

Who is the listed applicant for IRON REAGENT?

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

What is the FDA product code for IRON REAGENT?

The FDA product code for IRON REAGENT is CFM.

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Other records listing Medical Analysis 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.

K042717MAS, DADE AND LIQUID ASSAYED DIABETES CONTROLK041194ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND HK040880MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3K032826MAS PAR TDMK032335MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TLK031890MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL

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Related Devices (Code: CFM)

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.

K984119WAKO L-TYPE FE, WAKO L-TYPE CALIBRATORWako Chemicals USA, Inc.K981581IRONAbbott LaboratoriesK932871UIBC FOR DISCREET RANDOM ACCESS ANALYZERCatachem, Inc.K913705ABBOTT QLUICKSTART IRON TEST, ITEM #5A29Em Diagnostic Systems, Inc.K912912SYNERMED SERUM IRON-600 REAGENT KITSynermed, Inc.K902918SYNERMED SERUM IRON REAGENT KITSynermed, Inc.

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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