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Company · US

Paragon Diagnostics, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1984. Name variants (Inc, Corp, punctuation) are merged.

7510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
CDX	Radioimmunoassay, Total Thyroxine	1
JZT	Fluorometer	1
KHQ	Radioassay, Triiodothyronine Uptake	1
KLQ	Radioimmunoassay, Amikacin	1
LCQ	Fluorescent Immunoassay Gentamicin	1
LCR	Fluorescent Immunoassay, Tobramycin	1
LER	Fluorescent Immunoassay, Theophylline	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
May 2, 1984	K841162	IMMPULSE GENTAMICIN ASSAY REAGENTS Paragon Diagnostics, Inc.	LCQ
May 2, 1984	K841161	IMMPULSE AMIKACIN ASSAY REAGENTS Paragon Diagnostics, Inc.	KLQ
Apr 18, 1984	K840852	IMMPULSE T4 ASSAY REAGENTS Paragon Diagnostics, Inc.	CDX
Apr 4, 1984	K840847	IMMPULSE TOBRAMYCIN ASSAY REAGENTS Paragon Diagnostics, Inc.	LCR
Apr 4, 1984	K840758	IMMPULSE THEOPHYLLINE ASSAY REAGENTS Paragon Diagnostics, Inc.	LER
Apr 1, 1984	K840853	IMMPULSE TBC ASSAY REAGENTS Paragon Diagnostics, Inc.	KHQ
Mar 23, 1984	K834070	IMMPULSE SYSTEM Paragon Diagnostics, Inc.	JZT

Latest recalls

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

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