H292

FDA 510(k) K942820 · Bartels, Inc.

Substantially Equivalent

510(k) numberK942820

Submission

Device name
H292
Applicant
Bartels, Inc.
Issaquah, WA, US
Received
June 15, 1994
Decision date
May 5, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KIR – Cells, Animal And Human, Cultured
Device class
Class I (low risk)
Regulation
21 CFR 864.2280
Specialty
Hematology

Other 510(k)s with product code KIR

510(k)DeviceApplicantDecision
K973214Fresh Cells HFFKIR · Traditional Diagnostic Hybrids, Inc.09/25/1997SE
K973213Fresh Cells LLC-MK2KIR · Traditional Diagnostic Hybrids, Inc.09/25/1997SE
K973212Fresh Cells WI-38KIR · Traditional Diagnostic Hybrids, Inc.09/25/1997SE
K973211Fresh Cells MV1LUKIR · Traditional Diagnostic Hybrids, Inc.09/25/1997SE
K973210Fresh Cells Nci H292KIR · Traditional Diagnostic Hybrids, Inc.09/25/1997SE
K973209Fresh Cells VeroKIR · Traditional Diagnostic Hybrids, Inc.09/25/1997SE
K971508RHMK II Cell Culture, an Expanded Primary Rhesus Monkey Kidney Cell CultureKIR · Traditional Bio-Whittaker, Inc., A Cambrex Co.09/17/1997SE
K972414FreshcellsKIR · Traditional Diagnostic Hybrids, Inc.08/29/1997SE
K965047Mink Lung Cell CultureKIR · Traditional Neogenex02/04/1997SE
K962782Freshfrozen Cells, HEP-2KIR · Traditional Diagnostic Hybrids, Inc.08/29/1996SE

More from Diagnostic Hybrids, Inc.

510(k)DeviceDecision
K962499Zymmune Autoreader-F Fluorescence Microplate ReaderJZT · Traditional 09/05/1996SE

Questions and answers

When was H292 cleared by the FDA?

H292 (K942820) received a 510(k) decision of Substantially Equivalent on May 5, 1995, 324 days after the submission was received.

What is the product code of K942820?

The FDA product code is KIR – Cells, Animal And Human, Cultured, a Class I (low risk) device regulated under 21 CFR 864.2280.