Home / 510(k) Clearances / K850737

510(k) K850737

TRANSPORT CULTURE MEDIUM by Roseville Medical Laboratoriesu — Product Code PPM

K850737 is an FDA 510(k) premarket notification submitted by Roseville Medical Laboratoriesu for the device "TRANSPORT CULTURE MEDIUM". The FDA issued a decision of Substantially Equivalent on March 20, 1985. The device falls under product code PPM (General Purpose Reagent), a Class I device regulated under 21 CFR 864.4010. Roseville Medical Laboratoriesu has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1985
Date Received
February 20, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
General Purpose Reagent
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test.

Other clearances by Roseville Medical Laboratoriesu

  • K850731 — CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP. TESTING (March 20, 1985)
  • K850734 — DIFFERENTIAL CULTURE MEDIUM (March 20, 1985)
  • K850733 — MULTIPURPOSE CULTURE MEDIUM (March 20, 1985)
  • K850732 — CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI (March 20, 1985)
  • K850738 — SUPPLEMENT FOR CULTURE MEDIUM (March 20, 1985)
  • K850736 — SELECTIVE CULTURE MEDIUM (March 20, 1985)
  • K850735 — ENRICHED CULTURE MEDIUM (March 16, 1985)

Other clearances for product code PPM

  • K871533 — TOMTEC GRAM STAINER DECOLORIZER (April 29, 1987)
  • K863550 — POTASSIUM HYDROXIDE 10% W/V (October 2, 1986)
  • K861890 — 100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2 (June 3, 1986)
  • K850916 — SPRAYFIX (March 25, 1985)
  • K850845 — 0.85% SALINE (March 20, 1985)
  • K842934 — DECOLORIZING FLUIC, ACID-ALCOHOL 3% (September 12, 1984)
  • K842863 — PRO-SOFT DEHYDRANT (August 21, 1984)
  • K842729 — DECOLORIZING FLUID (August 3, 1984)
  • K842070 — IDD DETERGENT (July 2, 1984)
  • K831619 — SODIUM HYPOCHLORITE 7% (July 28, 1983)

FDA data resources