510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Biotrol, USA, Inc.

Berwyn, PA, US

Biotrol, USA, Inc. appears in FDA device records in Berwyn, PA. FDA records list 46 510(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
46
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 46 510(k) clearances for Biotrol, USA, Inc. between 1987 and 1995. The busiest year on record is 1988, with 18. The most recent is 1995, with 1.

Clearances by year, as a table
510(k) clearance decisions for Biotrol, USA, Inc., by decision year
YearClearances
198711
198818
19899
19914
19922
19931
19951
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K934014VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANTLRJSubstantially Equivalent
K931141BIOTROL AMYLASE CNPG3CIJSubstantially Equivalent
K921855BIOTROL BICARBONATE STANDARDSJISSubstantially Equivalent
K921677BIOTROL MAGNESIUM (MAGON)JGJSubstantially Equivalent
K912795BIOTROL UIBC REAGENTJMOSubstantially Equivalent
K910721BIOTROL PROTEIN MULTILEVEL STANDARDSJISSubstantially Equivalent
K905683BIOTROL LACTATE DEHYDROGENASE (L-P)CFJSubstantially Equivalent
K905280BIOTROL BILIRUBIN C & T CONTROLJJXSubstantially Equivalent
K894544BIOTROL RUB-E.I.A. TEST GLFXSubstantially Equivalent
K891061BIOTROL CALCIUM MONOREACTIFCJYSubstantially Equivalent
K891286BIOTROL CHEMISTRY URINE CONTROLJJWSubstantially Equivalent
K890846BIOTROL URINE PROTEINS REAGENTJIRSubstantially Equivalent
K890395BIOTROL IRON REAGENTJIYSubstantially Equivalent
K890015BIOTROL CHLORIDECHJSubstantially Equivalent
K885094BIOTROL ALBUMINCIXSubstantially Equivalent
K885053BIOTROL URINE PROTEINS REAGENTJIRSubstantially Equivalent
K885041BIOTROL INORGANIC PHOSPHORUSCEOSubstantially Equivalent
K884480BIOTROL BILIRUBIN MONOREACTIFCICSubstantially Equivalent
K883428BIOTROL URIC ACID ENZYMATIQUE TRINDERKNKSubstantially Equivalent
K881742BIOTROL ALKALINE PHOSPHATASECJESubstantially Equivalent
K882189BIOTROL TOTAL PROTEIN H.P.CEKSubstantially Equivalent
K881856BIOTROL CREATININE H.P. REAGENTCGXSubstantially Equivalent
K881702BIOTROL TRIGLYCERIDES ENZYMATIQUE UV H.P.CDTSubstantially Equivalent
K881366BIOTROL BUN ENZYMATIQUE UV H.P.CDQSubstantially Equivalent
K881267BIOTROL CK MONOEACTIFJHXSubstantially Equivalent
K881311BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TESTJQBSubstantially Equivalent
K873294BIOTROL TOXO ELISA TEST GLGDSubstantially Equivalent
K873293BIOTROL TOXO ELISA TEST MLGDSubstantially Equivalent
K875304BIOTROL CALIBRANT LEVEL 2JIXSubstantially Equivalent
K875318BIOTROL CALIBRANT LEVEL 3JIXSubstantially Equivalent
K875288BIOTROL CALIBRANT LEVEL 1JIXSubstantially Equivalent
K875320BIOTROL URIC ACID ENZYMATIQUE UV H.P.CDOSubstantially Equivalent
K874809REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUMJJYSubstantially Equivalent
K874941BIOTROL BICARBONATE (CO2) UV HP)KHSSubstantially Equivalent
K874810REFERENCE ASSAYED CHEMISTRY CONTROL SERUMJJYSubstantially Equivalent
K873160BIOTROL TRIGLYCERIDES ENZYMATIQUE COLORCDTSubstantially Equivalent
K872831BIOTROL ALPHA AMYLASECIJSubstantially Equivalent
K873180BIOTROL MAGNESIUM CALMAGITEJGJSubstantially Equivalent
K873118BIOTROL REFERENCEJIXSubstantially Equivalent
K873116MULTI ANALYTE MIXTURES, CALIBRATORSJIXSubstantially Equivalent
K873117BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENTCGASubstantially Equivalent
K872785BIOTROL-33 PLUS ASSAYED CHEMISTRY CONTROL SERUMJJYSubstantially Equivalent
K872777BIOTROL-33 PLUS PATHOLOGIQUE ASSAYED CHEM. CONTROLJJYSubstantially Equivalent
K872930BIOTROL CHOLESTEROL ENZYMATIQUE COLORCHHSubstantially Equivalent
K872830BIOTROL ALT/TGP MONOREACTIFCKASubstantially Equivalent
K872829BIOTROL AST/TGO MONOREACTIFCITSubstantially 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