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FDA 510(k)

EPIPACK

K-Number: K880999 · 1988-03-24

ApplicantClonetics Corp.
Decision Date1988-03-24
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

EPIPACK is the device name listed in this FDA 510(k) record. The listed applicant is Clonetics Corp.. It received FDA 510(k) clearance on 1988-03-24 under 510(k) number K880999. The device is classified under product code KIT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPIPACK?

EPIPACK is a medical device that received FDA 510(k) clearance on 1988-03-24. The listed applicant is Clonetics Corp.. The 510(k) number is K880999.

When did EPIPACK receive FDA 510(k) clearance?

EPIPACK received FDA 510(k) clearance on 1988-03-24, under 510(k) number K880999.

Who is the listed applicant for EPIPACK?

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

What is the FDA product code for EPIPACK?

The FDA product code for EPIPACK is KIT.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Clonetics Corp. 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.

K890700MELANOCYTE GROWTH MEDIUM (MGM)K890701ENDOTHELIAL GROWTH MEDIUM (EGM)K881000KERATINOCYTE GROWTH MEDIUM (KGM)

Related Devices (Code: KIT)

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.

K892938AMNIO-GROW TMInovar Biologicals, Inc.K890700MELANOCYTE GROWTH MEDIUM (MGM)Clonetics Corp.K890701ENDOTHELIAL GROWTH MEDIUM (EGM)Clonetics Corp.K890482ABC, ABC-1X, ABC(TM)Cell Ent., Inc.K884654ALPHACALF SERUMHyclone Laboratories, Inc.K884572RPMI-1640 HYBRI-MAX, PROD. NO. R5382Sigma Chemical Co.

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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