Elution Solution

FDA 510(k) K812565 · Biological Corp. of America

Substantially Equivalent

510(k) numberK812565

Submission

Device name
Elution Solution
Applicant
Biological Corp. of America
Mchenry, IL, US
Received
September 9, 1981
Decision date
October 23, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KSG – Media, Potentiating For In Vitro Diagnostic Use
Device class
Class II (moderate risk)
Regulation
21 CFR 864.9600
Specialty
Hematology

Other 510(k)s with product code KSG

510(k)DeviceApplicantDecision
K812222Em-XKSG · Traditional Biological Corp. of America09/23/1981SE
K800943Pentex Bovine Albumin 30% SolutionKSG · Traditional Miles Laboratories, Inc.05/08/1980SE
K800189Bovine Albumin 22% & 30% SolutionsKSG · Traditional Gotham Biologics, Inc.02/13/1980SE
K791791Ortho Antibody Enhancement SolutionKSG · Traditional Ortho Diagnostics, Inc.10/11/1979SE
K791113Low Ionic Strength Solution (Liss)KSG · Traditional Hyland Therapeutic Div., Travenol Laboratories06/28/1979SE
K790973Lo-IonKSG · Traditional Gamma Biologicals, Inc.06/15/1979SE
K790776Dade Low Ionic Strength Soluition (Liss)KSG · Traditional Dade, Baxter Travenol Diagnostics, Inc.05/23/1979SE
K790498Liss ReagentKSG · Traditional Fisher Scientific Co., LLC04/03/1979SE
K781435Ortho Low Ionic SolutionKSG · Traditional Ortho Diagnostics, Inc.09/14/1978SE
K781397Em-VKSG · Traditional Biological Corp. of America09/14/1978SE

More from Biological Corp. of America

510(k)DeviceDecision
K813404Freeze Dried FicinKSK · Traditional 02/10/1982SE
K812222Em-XKSG · Traditional 09/23/1981SE
K810803Freeze Dried PapainKSK · Traditional 07/21/1981SE
K781397Em-VKSG · Traditional 09/14/1978SE
K760162Hematology ControlJPK · Traditional 08/04/1976SE

Questions and answers

When was Elution Solution cleared by the FDA?

Elution Solution (K812565) received a 510(k) decision of Substantially Equivalent on October 23, 1981, 44 days after the submission was received.

What is the product code of K812565?

The FDA product code is KSG – Media, Potentiating For In Vitro Diagnostic Use, a Class II (moderate risk) device regulated under 21 CFR 864.9600.