FDA 510(k)

H292

K-Number: K942820 · 1995-05-05

Decision Date1995-05-05

Product CodeKIR

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

H292 is the device name listed in this FDA 510(k) record. The listed applicant is Bartels, Inc.. It received FDA 510(k) clearance on 1995-05-05 under 510(k) number K942820. 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 H292?

H292 is a medical device that received FDA 510(k) clearance on 1995-05-05. The listed applicant is Bartels, Inc.. The 510(k) number is K942820.

When did H292 receive FDA 510(k) clearance?

H292 received FDA 510(k) clearance on 1995-05-05, under 510(k) number K942820.

Who is the listed applicant for H292?

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

What is the FDA product code for H292?

The FDA product code for H292 is KIR.

Other records listing Bartels, 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.

K962499ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER

Related Devices (Code: KIR)

K973212FRESH CELLS WI-38Diagnostic Hybrids, Inc.K973210FRESH CELLS NCI H292Diagnostic Hybrids, Inc.K973209FRESH CELLS VERODiagnostic Hybrids, Inc.K973211FRESH CELLS MV1LUDiagnostic Hybrids, Inc.K973213FRESH CELLS LLC-MK2Diagnostic Hybrids, Inc.K973214FRESH CELLS HFFDiagnostic Hybrids, Inc.

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.