Fetal Check

FDA 510(k) K792546 · Alta Diagnostics, Inc.

Substantially Equivalent

510(k) numberK792546

Submission

Device name
Fetal Check
Applicant
Alta Diagnostics, Inc.
Mchenry, IL, US
Received
December 10, 1979
Decision date
December 18, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KJR – Erythrosin B
Device class
Class I (low risk)
Regulation
21 CFR 864.1850
Specialty
Hematology

Other 510(k)s with product code KJR

510(k)DeviceApplicantDecision
K842834HEP-2 CellsKJR · Traditional Bartels Immunodiagnostic Supplies, Inc.08/28/1984SE
K842833PMK Primary Monkey Kidney-CellsKJR · Traditional Bartels Immunodiagnostic Supplies, Inc.08/28/1984SE

More from Bartels Immunodiagnostic Supplies, Inc.

510(k)DeviceDecision
K800327Magnesium ReagentJGJ · Traditional 03/25/1980SE
K792545Uric Acid KitKNK · Traditional 01/29/1980SE
K790797Amylase Reagent SetKHM · Traditional 07/17/1979SE
K790796Lipase Reagent SetCET · Traditional 07/17/1979SE

Questions and answers

When was Fetal Check cleared by the FDA?

Fetal Check (K792546) received a 510(k) decision of Substantially Equivalent on December 18, 1979, 8 days after the submission was received.

What is the product code of K792546?

The FDA product code is KJR – Erythrosin B, a Class I (low risk) device regulated under 21 CFR 864.1850.