Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VITROGEN TM 100

K-Number: K812617 · 1981-10-02

ApplicantCollagen Corp.
Decision Date1981-10-02
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VITROGEN TM 100 is the device name listed in this FDA 510(k) record. The listed applicant is Collagen Corp.. It received FDA 510(k) clearance on 1981-10-02 under 510(k) number K812617. 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 VITROGEN TM 100?

VITROGEN TM 100 is a medical device that received FDA 510(k) clearance on 1981-10-02. The listed applicant is Collagen Corp.. The 510(k) number is K812617.

When did VITROGEN TM 100 receive FDA 510(k) clearance?

VITROGEN TM 100 received FDA 510(k) clearance on 1981-10-02, under 510(k) number K812617.

Who is the listed applicant for VITROGEN TM 100?

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

What is the FDA product code for VITROGEN TM 100?

The FDA product code for VITROGEN TM 100 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 Collagen 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.

K904671QAR HANDPIECEK904228OSSEODENT DENTAL ATTACHMENTS (NON-ANGLED)K901600OSSEOTITE IRRIGATION UNITK900275OSSEODENT DENTAL ATTACHMENT, IGLOO MAGNETK895462OSSEODENT DENTAL ATTACHMENTSK895463OSSEODENT(R) PRECISION DENTAL ATTACHMENTS

View all 9 devices →

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.

↑