Keratinocyte Growth Medium (KGM)

FDA 510(k) K881000 · Clonetics Corp.

Substantially Equivalent

510(k) numberK881000

Submission

Device name
Keratinocyte Growth Medium (KGM)
Applicant
Clonetics Corp.
San Diego, CA, US
Received
March 8, 1988
Decision date
March 21, 1988
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

Other 510(k)s with product code KIT

510(k)DeviceApplicantDecision
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
K890701Endothelial Growth Medium (Egm)KIT · Traditional 02/24/1989SE
K890700Melanocyte Growth Medium (MGM)KIT · Traditional 02/24/1989SE
K880999EpipackKIT · Traditional 03/24/1988SE

Questions and answers

When was Keratinocyte Growth Medium (KGM) cleared by the FDA?

Keratinocyte Growth Medium (KGM) (K881000) received a 510(k) decision of Substantially Equivalent on March 21, 1988, 13 days after the submission was received.

What is the product code of K881000?

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.