ClearanceBrief
Company ยท US

Cala Diagnostics

FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 1994. Name variants (Inc, Corp, punctuation) are merged.

12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
JJTEnzyme Controls (Assayed And Unassayed)6
DKCAlcohol Control Materials2
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)2
DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control1
LASDrug Specific Control Materials1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 31, 1994K944247CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL
Cala Diagnostics
JJT
Oct 31, 1994K944246CARDIOCHEX CKMB MASS MEASUREMENT CONTROL
Cala Diagnostics
JJT
Oct 27, 1994K944243CARDIOCHEX
Cala Diagnostics
JJT
Apr 22, 1993K930874LD-1 CONTROL-LEVEL 1 & 2
Cala Diagnostics
JJX
Apr 13, 1993K930875CKMB CONTROL - LEVEL 1,2,3
Cala Diagnostics
JJT
Apr 13, 1993K930873CKMB ISOENZYME CONTROL-LEVEL 1,2.3
Cala Diagnostics
JJT
Dec 28, 1992K926015CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3
Cala Diagnostics
JJX
Jan 30, 1992K915503FIBRINOGEN FDP CONTROL
Cala Diagnostics
DAP
Aug 12, 1991K912827SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3
Cala Diagnostics
DKC
Jul 26, 1991K912826WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2
Cala Diagnostics
DKC
May 6, 1987K864456CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3
Cala Diagnostics
LAS
Jun 25, 1985K850907CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/
Cala Diagnostics
JJT

Latest recalls

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