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FDA 510(k)

ULTRA ZYME PLUS ALP #64962, 65029 & 30

K-Number: K812596 · 1981-09-29

ApplicantHarleco
Decision Date1981-09-29
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRA ZYME PLUS ALP #64962, 65029 & 30 is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1981-09-29 under 510(k) number K812596. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRA ZYME PLUS ALP #64962, 65029 & 30?

ULTRA ZYME PLUS ALP #64962, 65029 & 30 is a medical device that received FDA 510(k) clearance on 1981-09-29. The listed applicant is Harleco. The 510(k) number is K812596.

When did ULTRA ZYME PLUS ALP #64962, 65029 & 30 receive FDA 510(k) clearance?

ULTRA ZYME PLUS ALP #64962, 65029 & 30 received FDA 510(k) clearance on 1981-09-29, under 510(k) number K812596.

Who is the listed applicant for ULTRA ZYME PLUS ALP #64962, 65029 & 30?

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 ALP #64962, 65029 & 30?

The FDA product code for ULTRA ZYME PLUS ALP #64962, 65029 & 30 is CJE.

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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: CJE)

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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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