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FDA 510(k)

ULTRA ZYME PLUS AMYL #64982 & 65031

K-Number: K812594 · 1981-10-02

ApplicantHarleco
Decision Date1981-10-02
Product CodeCIJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRA ZYME PLUS AMYL #64982 & 65031 is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1981-10-02 under 510(k) number K812594. 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 ULTRA ZYME PLUS AMYL #64982 & 65031?

ULTRA ZYME PLUS AMYL #64982 & 65031 is a medical device that received FDA 510(k) clearance on 1981-10-02. The listed applicant is Harleco. The 510(k) number is K812594.

When did ULTRA ZYME PLUS AMYL #64982 & 65031 receive FDA 510(k) clearance?

ULTRA ZYME PLUS AMYL #64982 & 65031 received FDA 510(k) clearance on 1981-10-02, under 510(k) number K812594.

Who is the listed applicant for ULTRA ZYME PLUS AMYL #64982 & 65031?

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

What is the FDA product code for ULTRA ZYME PLUS AMYL #64982 & 65031?

The FDA product code for ULTRA ZYME PLUS AMYL #64982 & 65031 is CIJ.

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Other records listing Harleco 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.

K820233ULTRAZYME PLUS GAMMA GT(65055-65056)K813427ULTRACHEM GLUC-DHK813044ULTRACHEM ALB, ITEM #64970K813042ULTRACHEM GLUC-DH SET, ITEM #65048K813038ULTRACHEM TP, ITEM #64974K813041ULTRAZYME-GT, ITEM #64959 & 65032

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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.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.,

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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