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FDA 510(k)

AMYLASE (ETHYLIDENE PNGPG7) KIT

K-Number: K953211 · 1996-06-21

ApplicantRandox Laboratories, Ltd.
Decision Date1996-06-21
Product CodeCIJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMYLASE (ETHYLIDENE PNGPG7) KIT is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories, Ltd.. It received FDA 510(k) clearance on 1996-06-21 under 510(k) number K953211. 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 (ETHYLIDENE PNGPG7) KIT?

AMYLASE (ETHYLIDENE PNGPG7) KIT is a medical device that received FDA 510(k) clearance on 1996-06-21. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K953211.

When did AMYLASE (ETHYLIDENE PNGPG7) KIT receive FDA 510(k) clearance?

AMYLASE (ETHYLIDENE PNGPG7) KIT received FDA 510(k) clearance on 1996-06-21, under 510(k) number K953211.

Who is the listed applicant for AMYLASE (ETHYLIDENE PNGPG7) KIT?

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

What is the FDA product code for AMYLASE (ETHYLIDENE PNGPG7) KIT?

The FDA product code for AMYLASE (ETHYLIDENE PNGPG7) KIT is CIJ.

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Other records listing Randox Laboratories, Ltd. 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.

K230890ISE ElectrodesK182042Randox Calcium (Ca)K162200Randox RX Daytona Plus Magnesium (MG)K152085Liquid CO2-2 (LCO2-2)K153435Direct HDL Cholesterol (HDL)K123977RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR

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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.

K023396AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)Pointe Scientific, Inc.,K991817ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEMBayer Corp.K980013AMYLASEAc Biochemicals, Inc.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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