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)

AMNIO-GROW TM

K-Number: K892938 · 1989-05-22

ApplicantInovar Biologicals, Inc.
Decision Date1989-05-22
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AMNIO-GROW TM is the device name listed in this FDA 510(k) record. The listed applicant is Inovar Biologicals, Inc.. It received FDA 510(k) clearance on 1989-05-22 under 510(k) number K892938. 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 AMNIO-GROW TM?

AMNIO-GROW TM is a medical device that received FDA 510(k) clearance on 1989-05-22. The listed applicant is Inovar Biologicals, Inc.. The 510(k) number is K892938.

When did AMNIO-GROW TM receive FDA 510(k) clearance?

AMNIO-GROW TM received FDA 510(k) clearance on 1989-05-22, under 510(k) number K892938.

Who is the listed applicant for AMNIO-GROW TM?

The FDA 510(k) record lists Inovar Biologicals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMNIO-GROW TM?

The FDA product code for AMNIO-GROW TM 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

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.

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.K884574DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785Sigma 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.

↑