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Chrono-Log Corp.

Havertown, PA, US

CHRONO-LOG CORP. appears in FDA device records in Havertown, PA. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
16
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 16 510(k) clearances for Chrono-Log Corp. between 1976 and 2016. The busiest year on record is 1976, with 2. The most recent is 2016, with 1.

Clearances by year, as a table
510(k) clearance decisions for Chrono-Log Corp., by decision year
YearClearances
19762
19771
19781
19821
19831
19852
19921
19931
19941
19951
19961
20041
20051
20161
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K161329Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channelJOZSubstantially Equivalent
K050265CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700JOZSubstantially Equivalent
K032951CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592AJOZSubstantially Equivalent
K962426CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592JOZSubstantially Equivalent
K945414RISTOCETIN COFACTOR ASSAY KITGGPSubstantially Equivalent
K940792AGGRO/LINK VW COFACTOR SOFTWAREJOZSubstantially Equivalent
K932566AGGRO/LINK CONTROL SOFTWAREJBXSubstantially Equivalent
K922800PLATELET AGGREGATION REAGENTSGHRSubstantially Equivalent
K851025AGGRO/LINK COMPUTER INTERFACEJBXSubstantially Equivalent
K850592PLATELET AGGREGATION REAGENTJBXSubstantially Equivalent
K830749PLATELET AGGREGOMETERJBXSubstantially Equivalent
K820422PLATELET AGGREGOMETERSGHRSubstantially Equivalent
K781807REAGENT, FIREFLY #395JOZSubstantially Equivalent
K771198LUMI-AGGREGOMETERJBYSubstantially Equivalent
K760159AGGREGOMETER, DUAL CHANNEL PLATELETJBXSubstantially Equivalent
K760198KIT, PLATELET AGGREGATION REAGENT (#390)GHRSubstantially Equivalent

Registered establishments

FDA registered establishments for Chrono-Log Corp., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
25181522518152CHRONO-LOG CORP.2 WEST PARK RD., HAVERTOWN, PA 19083 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

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

Verification record

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