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FDA 510(k)

ACE IRON REAGENT

K-Number: K944911 · 1995-02-10

ApplicantSchiapparelli Biosystems, Inc.
Decision Date1995-02-10
Product CodeJIY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACE IRON REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Schiapparelli Biosystems, Inc.. It received FDA 510(k) clearance on 1995-02-10 under 510(k) number K944911. 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 ACE IRON REAGENT?

ACE IRON REAGENT is a medical device that received FDA 510(k) clearance on 1995-02-10. The listed applicant is Schiapparelli Biosystems, Inc.. The 510(k) number is K944911.

When did ACE IRON REAGENT receive FDA 510(k) clearance?

ACE IRON REAGENT received FDA 510(k) clearance on 1995-02-10, under 510(k) number K944911.

Who is the listed applicant for ACE IRON REAGENT?

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

What is the FDA product code for ACE IRON REAGENT?

The FDA product code for ACE IRON REAGENT is JIY.

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Other records listing Schiapparelli Biosystems, 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.

K991733ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLSK981377ACE T4 REAGENT T4 CALIBRATORSK981375ACE T UPTAKE REAGENT TU CALIBRATORSK973581ACE VALPROIC ACID REAGENT, AED CALIBRATORSK973583ACE THEOPHYLLINE REAGENT, THEO CALIBRATORSK973582ACE PRIMIDONE REAGENT, AED CALIBRATORS

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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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