Rpmi 1640 W/Glutamine W/Hepes

FDA 510(k) K860282 · Newport Biosystems, Inc.

Substantially Equivalent

510(k) numberK860282

Submission

Device name
Rpmi 1640 W/Glutamine W/Hepes
Applicant
Newport Biosystems, Inc.
Santa Ana, CA, US
Received
January 28, 1986
Decision date
February 5, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KIT – Media And Components, Synthetic Cell And Tissue Culture
Device class
Class I (low risk)
Regulation
21 CFR 864.2220
Specialty
Hematology

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K892938Amnio-Grow TMKIT · Traditional Inovar Biologicals, Inc.05/22/1989SE
K890701Endothelial Growth Medium (Egm)KIT · Traditional Clonetics Corp.02/24/1989SE
K890700Melanocyte Growth Medium (MGM)KIT · Traditional Clonetics Corp.02/24/1989SE
K890482Abc, ABC-1X, Abc(Tm)KIT · Traditional Cell Ent., Inc.02/10/1989SE
K884654Alphacalf SerumKIT · Traditional Hyclone Laboratories, Inc.11/30/1988SE
K884574Dme & Ham's Nutrient Mixture, Prod. No. D9785KIT · Traditional Sigma Chemical Co.11/22/1988SE
K884573HBSS W/O Calc Chlor/Mag Sulf/Phen Red/Sb No. H4891KIT · Traditional Sigma Chemical Co.11/22/1988SE
K884572RPMI-1640 Hybri-Max, Prod. No. R5382KIT · Traditional Sigma Chemical Co.11/22/1988SE
K883065Alloprep SystemKIT · Traditional Osteotech, Inc.10/13/1988SE
K884031FBS, Eq., or Fetal Bovine Serum EquivalentKIT · Traditional Regency Biotech10/06/1988SE

More from Regency Biotech

510(k)DeviceDecision
K881648Transfer Container HumidifierCAF · Traditional 12/30/1988SE
K855085Tissue Culture MediaKIT · Traditional 01/13/1986SE
K853441Fetal Bovine Serum in Transfer ContainerKJA · Traditional 08/26/1985SE

Questions and answers

When was Rpmi 1640 W/Glutamine W/Hepes cleared by the FDA?

Rpmi 1640 W/Glutamine W/Hepes (K860282) received a 510(k) decision of Substantially Equivalent on February 5, 1986, 8 days after the submission was received.

What is the product code of K860282?

The FDA product code is KIT – Media And Components, Synthetic Cell And Tissue Culture, a Class I (low risk) device regulated under 21 CFR 864.2220.