P and T Medium

FDA 510(k) K904773 · Gibson Laboratories, Inc.

Substantially Equivalent

510(k) numberK904773

Submission

Device name
P and T Medium
Applicant
Gibson Laboratories, Inc.
Lexington, KY, US
Received
October 22, 1990
Decision date
December 4, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JTW – System, Transport, Aerobic
Device class
Class I (low risk)
Regulation
21 CFR 866.2900
Specialty
Microbiology

Other 510(k)s with product code JTW

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K121039Copan Mswab Collection, Transport and Preservation SystemJTW · Traditional Copan Flock Technologies05/25/2012SE
K061301Copan Liquid Amies Elution Swab (Eswab) Collection and Transport SystemJTW · Traditional Copan Diagnostics, Inc.06/23/2006SE
K022874Gen-Probe Aptima Combo 2 AssayJTW · Traditional Gen-Probe, Inc.09/17/2002SE
K013819Urine Collection, Preservation and Transport SystemJTW · Traditional Sierra Diagnostic, LLC02/28/2002SE
K993161Copan Easy-Swab Collection and Transport SystemJTW · Traditional Copan Diagnostics, Inc.11/09/1999SE
K983244Sensititre 18-24 HR Susceptibility Plates(Addition of Meropenem)JTW · Traditional Trek Diagnostic Systems, Inc.11/30/1998SE
K961148Cefepime Dispans-O-Disc (Cefeplime - 30MCG)JTW · Traditional Difco Laboratories, Inc.04/26/1996SE
K934894Cultureswab Transport SystemJTW · Traditional Difco Laboratories, Inc.02/22/1994SE
K895187FDL, Inc.'s Transport SystemJTW · Traditional Fairleigh Dickinson Laboratories, Inc.10/24/1989SE
K882580Mechanical Change in In-Vitro Micro DeviceJTW · Traditional Precision Dynamics Corp.07/08/1988SE

More from Precision Dynamics Corp.

510(k)DeviceDecision
K955826Gibson Id-M. Cat.JTO · Traditional 02/29/1996SE
K953247Gibson Id A.E. TestJTO · Traditional 11/20/1995SE
K905120Saf FixativeLIO · Traditional 12/17/1990SE

Questions and answers

When was P and T Medium cleared by the FDA?

P and T Medium (K904773) received a 510(k) decision of Substantially Equivalent on December 4, 1990, 43 days after the submission was received.

What is the product code of K904773?

The FDA product code is JTW – System, Transport, Aerobic, a Class I (low risk) device regulated under 21 CFR 866.2900.