Sterile Defibrinated Sheep Blood

FDA 510(k) K790801 · Central Biological Co.

Substantially Equivalent

510(k) numberK790801

Submission

Device name
Sterile Defibrinated Sheep Blood
Applicant
Central Biological Co.
Mchenry, IL, US
Received
April 19, 1979
Decision date
May 3, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JSK – Supplement, Culture Media
Device class
Class I (low risk)
Regulation
21 CFR 866.2450
Specialty
Microbiology

Other 510(k)s with product code JSK

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K881949Ats Nac-Pac SetJSK · Traditional Alpha-Tec Systems, Inc.05/25/1988SE
K881879Ats M/15 Phosphate Buffer, Product #034-42JSK · Traditional Alpha-Tec Systems, Inc.05/13/1988SE
K881566Hemoglobin PowderJSK · Traditional Acumedia Manufacturers, Inc.04/18/1988SE
K861997Penicillin-Streptomycin-Fungizone MixtureJSK · Traditional Hazleton Research Products, Inc.06/10/1986SE
K861824Gentamicin Sulfate Solution (10MG Gentamicin)JSK · Traditional Flow Laboratories, Inc.05/20/1986SE
K861823Gentamicin Sulfate Solution (50MG Gentamicin)JSK · Traditional Flow Laboratories, Inc.05/20/1986SE
K861791Penicillin-Streptomycin-FungizoneJSK · Traditional Flow Laboratories, Inc.05/20/1986SE
K855172Kwi (TM) G-Co/TwoJSK · Traditional Micro-Bio-Logics02/20/1986SE
K853546Abbott Cation Supplement SolutionJSK · Traditional Abbott Laboratories09/06/1985SE
K850302Suplex & Suplex DiluentJSK · Traditional Pro-Lab, Inc.03/22/1985SE

More from Pro-Lab, Inc.

510(k)DeviceDecision
K812330Dialysate ConcentrateFKQ · Traditional 09/29/1981SE
K792238CrptellDCK · Traditional 11/30/1979SE
K792027Pregtell IJHJ · Traditional 10/30/1979SE
K790351RheumatellDHR · Traditional 03/15/1979SE

Questions and answers

When was Sterile Defibrinated Sheep Blood cleared by the FDA?

Sterile Defibrinated Sheep Blood (K790801) received a 510(k) decision of Substantially Equivalent on May 3, 1979, 14 days after the submission was received.

What is the product code of K790801?

The FDA product code is JSK – Supplement, Culture Media, a Class I (low risk) device regulated under 21 CFR 866.2450.