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FDA 510(k)

GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*

K-Number: K772033 · 1977-11-17

ApplicantHarleco
Decision Date1977-11-17
Product CodeJMK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP* is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1977-11-17 under 510(k) number K772033. The device is classified under product code JMK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*?

GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP* is a medical device that received FDA 510(k) clearance on 1977-11-17. The listed applicant is Harleco. The 510(k) number is K772033.

When did GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP* receive FDA 510(k) clearance?

GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP* received FDA 510(k) clearance on 1977-11-17, under 510(k) number K772033.

Who is the listed applicant for GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*?

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 GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*?

The FDA product code for GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP* is JMK.

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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: JMK)

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.

K983860MTM BIOSCANNER K TEST STRIPS, CAT # BSA610Polymer Technology Systems, Inc.K981865MTM BIOSCANNER K TEST STRIPSPolymer Technology Systems, Inc.K953452KETOREX C SANWAIhara Medics U.S., Inc.K941427SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)Teco DiagnosticsK862319HBDH (OPTIMIZED) REAGENTSigma Chemical Co.K843774RAICHEM X-HBDH REAGENTReagents Applications, 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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