Protect T.M.

FDA 510(k) K871121 · Pro-Lab, Inc.

Substantially Equivalent

510(k) numberK871121

Submission

Device name
Protect T.M.
Applicant
Pro-Lab, Inc.
Scarborough Ont, CA
Received
March 19, 1987
Decision date
April 14, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JTR – Kit, Quality Control For Culture Media
Device class
Class I (low risk)
Regulation
21 CFR 866.2480
Specialty
Microbiology

Other 510(k)s with product code JTR

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K862914Fekal Check Parasitology Control SlideJTR · Traditional Trend Scientific, Inc.09/16/1986SE
K861022Kwik Stik(Tm) Lyfo(Tm) Disk MicroorganismsJTR · Traditional Micro-Bio-Logics04/04/1986SE
K855198Indi Kwik (TM) Co/Two KitJTR · Traditional Micro-Bio-Logics01/14/1986SE
K842579B.E.C. Growth Chek Microbial SuspensionsJTR · Traditional Biological & Environmental Control Laboratories07/27/1984SE
K842129Lyfo-Disk MicroorganismsJTR · Traditional Micro-Bio-Logics07/03/1984SE
K831653Lyophilized MicroorganismsJTR · Traditional Austin Biological Laboratories07/28/1983SE
K830133Q-Check Culti-LoopsJTR · Traditional Lab Ability, Inc.02/09/1983SE
K822954Microtech Bacterial ControlsJTR · Traditional Universal Micro Reference Laboratory11/16/1982SE
K821660Bio-Check Gram Stain ControlJTR · Traditional American Scientific Products06/25/1982SE
K820064SusceptrolJTR · Traditional American Type Culture Collection01/28/1982SE

More from American Type Culture Collection

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K914419Amniotest(Tm)HIO · Traditional 09/01/1993SE
K921421Legionella Reagens for Direct Fluorescent AntibodyLHL · Traditional 07/28/1992SE
K903714E. Coli 0157 Latex TestGNA · Traditional 01/24/1991SE
K894221Rosco PyrrJTO · Traditional 09/28/1989SE
K883996X-Act Ldc/IndJSE · Traditional 10/12/1988SE
K883995X-Act Urea/TdaJSE · Traditional 10/12/1988SE
K870117Neisseria/Branhamella Differential TestJSX · Traditional 03/20/1987SE
K861142Master Kit BLRP · Traditional 07/10/1986SESD
K861889D'Ala Rapid TestJTO · Traditional 06/03/1986SE

Questions and answers

When was Protect T.M. cleared by the FDA?

Protect T.M. (K871121) received a 510(k) decision of Substantially Equivalent on April 14, 1987, 26 days after the submission was received.

What is the product code of K871121?

The FDA product code is JTR – Kit, Quality Control For Culture Media, a Class I (low risk) device regulated under 21 CFR 866.2480.