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Company · US

Btc Diagnostics, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 1984. 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
CED	5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase	1
CEP	Radioimmunoassay, Luteinizing Hormone	1
JHI	Visual, Pregnancy Hcg, Prescription Use	1
JHJ	Agglutination Method, Human Chorionic Gonadotropin	1
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Nov 27, 1984	K841545	ENZYME IMMUNOASSAY FOR DETECTION HORM Btc Diagnostics, Inc.	CEP
Feb 3, 1984	K832905	QUALITATIVE ENZYME IMMUNOASSAY-DETECT Btc Diagnostics, Inc.	LCX
Jan 30, 1984	K833710	BTC URINE LH ASSAY Btc Diagnostics, Inc.	CED
Jul 19, 1983	K831604	HCG ACCU-STICK Btc Diagnostics, Inc.	JHI
May 5, 1983	K831125	BTC URINE LCG ASSAY Btc Diagnostics, Inc.	JHJ

Latest recalls

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

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