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)

FRESH CELLS MV1LU

K-Number: K973211 · 1997-09-25

ApplicantDiagnostic Hybrids, Inc.
Decision Date1997-09-25
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FRESH CELLS MV1LU is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Hybrids, Inc.. It received FDA 510(k) clearance on 1997-09-25 under 510(k) number K973211. The device is classified under product code KIR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRESH CELLS MV1LU?

FRESH CELLS MV1LU is a medical device that received FDA 510(k) clearance on 1997-09-25. The listed applicant is Diagnostic Hybrids, Inc.. The 510(k) number is K973211.

When did FRESH CELLS MV1LU receive FDA 510(k) clearance?

FRESH CELLS MV1LU received FDA 510(k) clearance on 1997-09-25, under 510(k) number K973211.

Who is the listed applicant for FRESH CELLS MV1LU?

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

What is the FDA product code for FRESH CELLS MV1LU?

The FDA product code for FRESH CELLS MV1LU is KIR.

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 Diagnostic Hybrids, 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.

K092229THYRETAIN TM TSI REPORTER BIOASSAYK093415D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KITK093233D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KITK092882D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KITK091171D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KITK091753ELVIS HSV ID AND D3 TYPING TEST SYSTEM

View all 36 devices →

Related Devices (Code: KIR)

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.

K973213FRESH CELLS LLC-MK2Diagnostic Hybrids, Inc.K973214FRESH CELLS HFFDiagnostic Hybrids, Inc.K973209FRESH CELLS VERODiagnostic Hybrids, Inc.K973212FRESH CELLS WI-38Diagnostic Hybrids, Inc.K973210FRESH CELLS NCI H292Diagnostic Hybrids, Inc.K971508RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTUREBio-Whittaker, Inc., A Cambrex 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.

↑