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FDA 510(k)

SERUM IRON/VIBC REAGENT SET

K-Number: K852161 · 1985-06-10

ApplicantLivonia Diagnostics, Inc.
Decision Date1985-06-10
Product CodeJIY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERUM IRON/VIBC REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Livonia Diagnostics, Inc.. It received FDA 510(k) clearance on 1985-06-10 under 510(k) number K852161. 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/VIBC REAGENT SET?

SERUM IRON/VIBC REAGENT SET is a medical device that received FDA 510(k) clearance on 1985-06-10. The listed applicant is Livonia Diagnostics, Inc.. The 510(k) number is K852161.

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

SERUM IRON/VIBC REAGENT SET received FDA 510(k) clearance on 1985-06-10, under 510(k) number K852161.

Who is the listed applicant for SERUM IRON/VIBC REAGENT SET?

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

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

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

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Other records listing Livonia Diagnostics, Inc. as applicant

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Related Devices (Code: JIY)

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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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