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FDA 510(k)

IRON TEST

K-Number: K881202 · 1988-04-28

ApplicantSclavo, Inc.
Decision Date1988-04-28
Product CodeJIY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IRON TEST is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1988-04-28 under 510(k) number K881202. 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 IRON TEST?

IRON TEST is a medical device that received FDA 510(k) clearance on 1988-04-28. The listed applicant is Sclavo, Inc.. The 510(k) number is K881202.

When did IRON TEST receive FDA 510(k) clearance?

IRON TEST received FDA 510(k) clearance on 1988-04-28, under 510(k) number K881202.

Who is the listed applicant for IRON TEST?

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

What is the FDA product code for IRON TEST?

The FDA product code for IRON TEST is JIY.

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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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