510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Ciba Corning Diagnostics Corp.

East Walpole, MA, US

Ciba Corning Diagnostics Corp. appears in FDA device records in East Walpole, MA. FDA records list 125 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
125
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 125

FDA records hold 125 510(k) clearances for Ciba Corning Diagnostics Corp. between 1986 and 1996. The busiest year on record is 1987, with 19. The most recent is 1996, with 10.

Clearances by year, as a table
510(k) clearance decisions for Ciba Corning Diagnostics Corp., by decision year
YearClearances
198611
198719
198811
198911
199011
199116
19929
19938
199410
19959
199610
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K962559ACS CORTISOL IMMUNOASSAYJFTSubstantially Equivalent
K963251CIBA CORNING ACS;180 DPD ASSAYJMMSubstantially Equivalent
K961807CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4GLKSubstantially Equivalent
K961657CIBA CORNING 400 SYSTEMCHLSubstantially Equivalent
K962021CIBA CORNING 348 SYSTEMCHLSubstantially Equivalent
K962126ACS CKMB II IMMUNOASSAYJHSSubstantially Equivalent
K962041ACS LH2 IMMUNOASSAYCEPSubstantially Equivalent
K961510ACS FRT4 IMMUNOASSAYJJXSubstantially Equivalent
K960246LIQUID CARDIAC MARKER 1,2,3 ASSAYEDJJTSubstantially Equivalent
K955873ACS PHENYTOIN ASSAYLGRSubstantially Equivalent
K954697CIBA CORNING ACS ESTRADIOL-6 ASSAYCHPSubstantially Equivalent
K953021ACS PHENOBARBITALDISSubstantially Equivalent
K953020ACS GENTAMICINLCDSubstantially Equivalent
K951169CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAYLGSSubstantially Equivalent
K951059CIBA CORNING ACS VANCOMYCIN IMMUNOASSAYLEHSubstantially Equivalent
K951796CIBA CORNING ACS THYROID STIMULATING HORMONE (TSH-3) IMMUNOASSAYJLWSubstantially Equivalent
K945367CIBA CORNING ACS CORTISOL IMMUNOASSAYCGRSubstantially Equivalent
K946224CERTAIN(R) ELITE LEVEL 1, 2 AND 3JJSSubstantially Equivalent
K946206CIBA CORNING 8-- SERIES CO-OXIMETERCHLSubstantially Equivalent
K943297CIBA CORNING ACS FOLATE ASSAYCGNSubstantially Equivalent
K935228MODEL 644 SWEAT DILUENTCGZSubstantially Equivalent
K940810CIBA CORNING ACS:180 AUTO CHEMILUMIN SYST, MODIFJJESubstantially Equivalent
K934317CIDBA CORNING ACS CORTISOL IMMUNOASSAYJFTSubstantially Equivalent
K940482CIBA CORNING ACS FT3 IMMUNOASSAYCECSubstantially Equivalent
K934594MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEMDGCSubstantially Equivalent
K930534TMC I, IIJJYSubstantially Equivalent
K935219FERTILITY PLUS 1, 2, 3JJYSubstantially Equivalent
K935830CIBA CORNING 248 PH/BLOOD GAS ANALYZERCHLSubstantially Equivalent
K934907860 MEASURMENT SYSTEMCHLSubstantially Equivalent
K934562CIBA CORNING ACS TESTOSTERONE IMMUNOASSAYCDZSubstantially Equivalent
K932747CIBA CORNING ACS FREE T3 IMMUNOASSAYCDPSubstantially Equivalent
K932715CIBA CORNING ACS ESTRADIOL IMMUNOASSAYCHPSubstantially Equivalent
K933373CIBA CORNING 300 SERIES SYSTEMJGSSubstantially Equivalent
K932955CIBA CORNING ACS PROGESTERONE IMMUNOASSAYJLSSubstantially Equivalent
K931213ACS DIGOXIN IMMUNOASSAYKXTSubstantially Equivalent
K925277CIBA CORNING ACS HCG IMMUNOASSAYJHISubstantially Equivalent
K923420CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAYDHBSubstantially Equivalent
K925257CIBA CORNING ACS T UPTAKE IMMUNOASSAYKHQSubstantially Equivalent
K923633MULTIQUAL ASSAY PRODUCTSJJYSubstantially Equivalent
K923632MULTIQUAL UNASSAYED PRODUCTSJJYSubstantially Equivalent
K914959MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEMDHBSubstantially Equivalent
K921403MODEL 654 ANALYZERJIHSubstantially Equivalent
K921678CIBA CORNING ACS FOLATE IMMUNOASSAYJIXSubstantially Equivalent
K920372ACS TOTAL IGE IMMUNOASSAYDGCSubstantially Equivalent
K915366MODEL 560 EXPRESS CLINICAL CHEMISTRY ANALYZERJJESubstantially Equivalent
K915332MODEL 795 FLUOROMETER/DENSITOMETERJQTSubstantially Equivalent
K914619CVMJJYSubstantially Equivalent
K913646CIBA CORNING ACS T3 IMMUNOASSAYCDDSubstantially Equivalent
K913332CIBA CORNING MODEL 270 CO-OXIMETERDQASubstantially Equivalent
K912583MAGIC LITE TSH (HS) IMMUNOASSAYJLWSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

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Data as of , FDA export datePage updated Source: openFDA, public domain