Lysing Agent Af

FDA 510(k) K761183 · Central Labs. Assoc. MD Pathologists

Substantially Equivalent

510(k) numberK761183

Submission

Device name
Lysing Agent Af
Applicant
Central Labs. Assoc. MD Pathologists
Mchenry, IL, US
Received
December 2, 1976
Decision date
January 17, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JCE – Solution, Isotonic
Device class
Class I (low risk)
Regulation
21 CFR 864.4010
Specialty
Pathology

Other 510(k)s with product code JCE

510(k)DeviceApplicantDecision
K842722Buffered SalineJCE · Traditional E K Ind., Inc.09/11/1984SE
K831200Immunohematological Saline #97139JCE · Traditional Emd Chemicals, Inc.05/09/1983SE
K801506Certified Blood Bank SalineJCE · Traditional Nobel Scientific Industries, Inc.07/28/1980SE
K792101Couiter/Cms Isotonic Blood Bank SalineJCE · Traditional Coulter Electronics, Inc.11/20/1979SE
K761174Physiologic Saline (0.85%)JCE · Traditional Bio/Data Corp.01/10/1977SE
K761170Barbital Saline BufferJCE · Traditional Bio/Data Corp.01/10/1977SE

More from Bio/Data Corp.

510(k)DeviceDecision
K771201Formalin Buffer ConcentrateIGG · Traditional 08/22/1977SE
K761182Isotonic Diluent AfGGK · Traditional 12/09/1976SE

Questions and answers

When was Lysing Agent Af cleared by the FDA?

Lysing Agent Af (K761183) received a 510(k) decision of Substantially Equivalent on January 17, 1977, 46 days after the submission was received.

What is the product code of K761183?

The FDA product code is JCE – Solution, Isotonic, a Class I (low risk) device regulated under 21 CFR 864.4010.