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FDA 510(k)

KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT

K-Number: K890573 · 1989-03-24

ApplicantKenlor Industries, Inc.
Decision Date1989-03-24
Product CodeJIY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Kenlor Industries, Inc.. It received FDA 510(k) clearance on 1989-03-24 under 510(k) number K890573. 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 KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT?

KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT is a medical device that received FDA 510(k) clearance on 1989-03-24. The listed applicant is Kenlor Industries, Inc.. The 510(k) number is K890573.

When did KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT receive FDA 510(k) clearance?

KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT received FDA 510(k) clearance on 1989-03-24, under 510(k) number K890573.

Who is the listed applicant for KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT?

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

What is the FDA product code for KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT?

The FDA product code for KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT is JIY.

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Other records listing Kenlor Industries, 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.

K964014KENLOR H. PYLORI CONTROL SERUMK952840KENLOR LIQUID TOTAL URINE CONTROLK950326KENLOR HUMAN SPINAL FLUID CONTROLK903338KENLOR THERAPEUTIC DRUG MONITORING (TDM) CONTROLK896440KENLOR PYROGALLOL RED MICROPROTEIN ASSAY KITK890618COOMASSIE BLUE TOTAL PROTEIN ASSAY 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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