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FDA 510(k)

AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)

K-Number: K023396 · 2002-12-23

ApplicantPointe Scientific, Inc.,
Decision Date2002-12-23
Product CodeCIJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) 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 2002-12-23 under 510(k) number K023396. The device is classified under product code CIJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)?

AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) is a medical device that received FDA 510(k) clearance on 2002-12-23. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K023396.

When did AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) receive FDA 510(k) clearance?

AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) received FDA 510(k) clearance on 2002-12-23, under 510(k) number K023396.

Who is the listed applicant for AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)?

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 AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)?

The FDA product code for AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) is CIJ.

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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: CIJ)

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.

K991817ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEMBayer Corp.K980013AMYLASEAc Biochemicals, Inc.K953211AMYLASE (ETHYLIDENE PNGPG7) KITRandox Laboratories, Ltd.K951494AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)Emd Chemicals, Inc.K940735LIQUID AMYLASE (CNPG3) REAGENT SETPointe Scientific, Inc.,K940010DMA AMYLASE (DEMAND) PROCEDUREData Medical Associates, Inc.

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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