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FDA 510(k)

SERUM IRON & IRON BINDING REAGENT SET

K-Number: K860478 · 1986-03-14

ApplicantSterling Diagnostics, Inc.
Decision Date1986-03-14
Product CodeJIY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERUM IRON & IRON BINDING REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Sterling Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-03-14 under 510(k) number K860478. 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 & IRON BINDING REAGENT SET?

SERUM IRON & IRON BINDING REAGENT SET is a medical device that received FDA 510(k) clearance on 1986-03-14. The listed applicant is Sterling Diagnostics, Inc.. The 510(k) number is K860478.

When did SERUM IRON & IRON BINDING REAGENT SET receive FDA 510(k) clearance?

SERUM IRON & IRON BINDING REAGENT SET received FDA 510(k) clearance on 1986-03-14, under 510(k) number K860478.

Who is the listed applicant for SERUM IRON & IRON BINDING REAGENT SET?

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

What is the FDA product code for SERUM IRON & IRON BINDING REAGENT SET?

The FDA product code for SERUM IRON & IRON BINDING REAGENT SET is JIY.

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Other records listing Sterling Diagnostics, 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.

K921412MICROPROTEIN REAGENT SETK914609TRIGLYCERIDES REAGENT SETK914039SODIUM REAGENT SETK914040PHOSPHOLIPID REAGENT SETK862255LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)K861962VANILMANDELIC ACID (VMA) REAGENT SET

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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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