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FDA 510(k)

LIQUID-STAT IRON REAGENT KIT & TIBC REAGENT KIT

K-Number: K870986 · 1987-04-13

ApplicantBeckman Instruments, Inc.
Decision Date1987-04-13
Product CodeJIY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIQUID-STAT IRON REAGENT KIT & TIBC REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1987-04-13 under 510(k) number K870986. 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 LIQUID-STAT IRON REAGENT KIT & TIBC REAGENT KIT?

LIQUID-STAT IRON REAGENT KIT & TIBC REAGENT KIT is a medical device that received FDA 510(k) clearance on 1987-04-13. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K870986.

When did LIQUID-STAT IRON REAGENT KIT & TIBC REAGENT KIT receive FDA 510(k) clearance?

LIQUID-STAT IRON REAGENT KIT & TIBC REAGENT KIT received FDA 510(k) clearance on 1987-04-13, under 510(k) number K870986.

Who is the listed applicant for LIQUID-STAT IRON REAGENT KIT & TIBC REAGENT KIT?

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

What is the FDA product code for LIQUID-STAT IRON REAGENT KIT & TIBC REAGENT KIT?

The FDA product code for LIQUID-STAT IRON REAGENT KIT & TIBC REAGENT KIT is JIY.

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Other records listing Beckman Instruments, Inc. as applicant

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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