Company · US

Omega Medical Diagnostics

FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 1983. Name variants (Inc, Corp, punctuation) are merged.

5510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
PPM	General Purpose Reagent	2
GGK	Products, Red-Cell Lysing Products	1
GIF	Diluent, Blood Cell	1
GKR	System, Hemoglobin, Automated	1

Decided	510(k)	Device and applicant	Code
Aug 12, 1983	K832182	LYSING REAGENT Omega Medical Diagnostics	GGK
Jul 28, 1983	K831620	SODIUM HYPOCHLORITE 3% Omega Medical Diagnostics	PPM
Jul 28, 1983	K831619	SODIUM HYPOCHLORITE 7% Omega Medical Diagnostics	PPM
Jun 16, 1983	K831618	HEMOGLOBIN REAGENT Omega Medical Diagnostics	GKR
Jun 16, 1983	K831617	DILUENT Omega Medical Diagnostics	GIF

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.