Hemogastat

FDA 510(k) K801148 · Therapac, Inc.

Substantially Equivalent

510(k) numberK801148

Submission

Device name
Hemogastat
Applicant
Therapac, Inc.
Mchenry, IL, US
Received
May 13, 1980
Decision date
June 9, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JRR – Regulator, Temperature
Device class
Class I (low risk)
Regulation
21 CFR 862.2050
Specialty
Clinical Chemistry

Other 510(k)s with product code JRR

510(k)DeviceApplicantDecision
K822132Dade Chill TrayJRR · Traditional American Dade08/05/1982SE
K780757KRYORACK/4JRR · Traditional Streck Laboratories, Inc.06/06/1978SE
K761337Aquamatic K-Module Model K-10JRR · Traditional Gorman Rupp Industries01/10/1977SE

Questions and answers

When was Hemogastat cleared by the FDA?

Hemogastat (K801148) received a 510(k) decision of Substantially Equivalent on June 9, 1980, 27 days after the submission was received.

What is the product code of K801148?

The FDA product code is JRR – Regulator, Temperature, a Class I (low risk) device regulated under 21 CFR 862.2050.