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)

MEM D-VAL MODIF. M7395, W/EBSS, L-GLUTAMINE, D-VAL

K-Number: K850922 · 1985-03-25

ApplicantSigma Chemical Co.
Decision Date1985-03-25
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MEM D-VAL MODIF. M7395, W/EBSS, L-GLUTAMINE, D-VAL is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1985-03-25 under 510(k) number K850922. 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 MEM D-VAL MODIF. M7395, W/EBSS, L-GLUTAMINE, D-VAL?

MEM D-VAL MODIF. M7395, W/EBSS, L-GLUTAMINE, D-VAL is a medical device that received FDA 510(k) clearance on 1985-03-25. The listed applicant is Sigma Chemical Co.. The 510(k) number is K850922.

When did MEM D-VAL MODIF. M7395, W/EBSS, L-GLUTAMINE, D-VAL receive FDA 510(k) clearance?

MEM D-VAL MODIF. M7395, W/EBSS, L-GLUTAMINE, D-VAL received FDA 510(k) clearance on 1985-03-25, under 510(k) number K850922.

Who is the listed applicant for MEM D-VAL MODIF. M7395, W/EBSS, L-GLUTAMINE, D-VAL?

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

What is the FDA product code for MEM D-VAL MODIF. M7395, W/EBSS, L-GLUTAMINE, D-VAL?

The FDA product code for MEM D-VAL MODIF. M7395, W/EBSS, L-GLUTAMINE, D-VAL 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 Sigma Chemical Co. 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.

K933694SIGMA GLUCOSE REAGENTK933678SIGMA CALCIUM REAGENTK933696SIGMA ELECTROLYTE REFERENCE REAGENTK933691SIGMA CO2 ALKALINE BUFFER REAGENTK933679SIGMA BUN REAGENTK933703SIGMA WASH CONCENTRATE SOLUTION

View all 231 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.

↑