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)

DPBS-DULBECCO'S PHOSPHATE BUFFERED SALINE

K-Number: K850525 · 1985-02-27

ApplicantMediatech, Inc.
Decision Date1985-02-27
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DPBS-DULBECCO'S PHOSPHATE BUFFERED SALINE is the device name listed in this FDA 510(k) record. The listed applicant is Mediatech, Inc.. It received FDA 510(k) clearance on 1985-02-27 under 510(k) number K850525. 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 DPBS-DULBECCO'S PHOSPHATE BUFFERED SALINE?

DPBS-DULBECCO'S PHOSPHATE BUFFERED SALINE is a medical device that received FDA 510(k) clearance on 1985-02-27. The listed applicant is Mediatech, Inc.. The 510(k) number is K850525.

When did DPBS-DULBECCO'S PHOSPHATE BUFFERED SALINE receive FDA 510(k) clearance?

DPBS-DULBECCO'S PHOSPHATE BUFFERED SALINE received FDA 510(k) clearance on 1985-02-27, under 510(k) number K850525.

Who is the listed applicant for DPBS-DULBECCO'S PHOSPHATE BUFFERED SALINE?

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

What is the FDA product code for DPBS-DULBECCO'S PHOSPHATE BUFFERED SALINE?

The FDA product code for DPBS-DULBECCO'S PHOSPHATE BUFFERED SALINE 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 Mediatech, Inc. 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.

K860623CELLGRO HEPES BUFFER SOLUTIONK854567PENICILLIN/STREPTOMYCIN SOLUTIONK852475CELLGRO WILLIAMS' MEDIUM EK852602MCCOY'S 5A MEDIUM-LIQUID FORMK852603MCCOY'S 5A MEDIUM - POWDERED FORMK852485CELLGRO(ISCOVE'S MEDIUM) MODIFICATION

View all 24 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.

↑