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FDA 510(k)

TOTAL IRON (NITRO-PAPS) REAGENT SET

K-Number: K961588 · 1996-11-18

ApplicantPointe Scientific, Inc.,
Decision Date1996-11-18
Product CodeJIY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL IRON (NITRO-PAPS) REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Pointe Scientific, Inc.,. It received FDA 510(k) clearance on 1996-11-18 under 510(k) number K961588. 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 TOTAL IRON (NITRO-PAPS) REAGENT SET?

TOTAL IRON (NITRO-PAPS) REAGENT SET is a medical device that received FDA 510(k) clearance on 1996-11-18. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K961588.

When did TOTAL IRON (NITRO-PAPS) REAGENT SET receive FDA 510(k) clearance?

TOTAL IRON (NITRO-PAPS) REAGENT SET received FDA 510(k) clearance on 1996-11-18, under 510(k) number K961588.

Who is the listed applicant for TOTAL IRON (NITRO-PAPS) REAGENT SET?

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

What is the FDA product code for TOTAL IRON (NITRO-PAPS) REAGENT SET?

The FDA product code for TOTAL IRON (NITRO-PAPS) REAGENT SET is JIY.

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Other records listing Pointe Scientific, 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.

K070757MICROPROTEIN REAGENT SETK062118POINTE 360K070251CARBON DIOXIDE LIQUID STABLE REAGENTK070207MULTI-ANALYTE CHEMISTRY CALIBRATORK070504AMMONIA/ALCOHOL CONTROL SETK061377APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND 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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