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FDA 510(k)

IRON KIT

K-Number: K810085 · 1981-01-28

ApplicantBio-Analytics Laboratories, Inc.
Decision Date1981-01-28
Product CodeCFM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IRON KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Analytics Laboratories, Inc.. It received FDA 510(k) clearance on 1981-01-28 under 510(k) number K810085. 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 KIT?

IRON KIT is a medical device that received FDA 510(k) clearance on 1981-01-28. The listed applicant is Bio-Analytics Laboratories, Inc.. The 510(k) number is K810085.

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

IRON KIT received FDA 510(k) clearance on 1981-01-28, under 510(k) number K810085.

Who is the listed applicant for IRON KIT?

The FDA 510(k) record lists Bio-Analytics Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IRON KIT?

The FDA product code for IRON KIT is CFM.

Other records listing Bio-Analytics Laboratories, Inc. as applicant

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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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