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FDA 510(k)

ULTRAZYME AMYLASE

K-Number: K760026 · 1976-09-21

ApplicantHarleco
Decision Date1976-09-21
Product CodeCIJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRAZYME AMYLASE is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1976-09-21 under 510(k) number K760026. 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 ULTRAZYME AMYLASE?

ULTRAZYME AMYLASE is a medical device that received FDA 510(k) clearance on 1976-09-21. The listed applicant is Harleco. The 510(k) number is K760026.

When did ULTRAZYME AMYLASE receive FDA 510(k) clearance?

ULTRAZYME AMYLASE received FDA 510(k) clearance on 1976-09-21, under 510(k) number K760026.

Who is the listed applicant for ULTRAZYME AMYLASE?

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 ULTRAZYME AMYLASE?

The FDA product code for ULTRAZYME AMYLASE 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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