ClearanceBrief
Company ยท US

Enzo Biochem, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 1988. 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

CodeDeviceRecords
GQNAntigen, Cf (Including Cf Control), Herpesvirus Hominis 1,22
GQHAntigen, Cf (Including Cf Control), Cytomegalovirus1
GQMAntisera, Neutralization, Herpesvirus Hominis1
KHEReagent, Occult Blood1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Aug 3, 1988K880604COLORGENE HSV DNA HYBRIDIZATION TEST
Enzo Biochem, Inc.
GQN
Jul 8, 1988K881907HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD
Enzo Biochem, Inc.
KHE
Mar 28, 1988K875367COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV
Enzo Biochem, Inc.
GQM
Dec 4, 1987K872576COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION
Enzo Biochem, Inc.
GQH
May 26, 1987K870733COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA.
Enzo Biochem, Inc.
GQN

Latest recalls

DateFirm and productCodeLinked 510(k)
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