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

Murrieta, CA, US

COPAN DIAGNOSTICS, INC. appears in FDA device records in Murrieta, CA. FDA records list 10 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
10
PMA records
0
Recall records
1
Registered establishments
2

510(k) clearance history

FDA records hold 10 510(k) clearances for COPAN Diagnostics, Inc. between 1995 and 2006. The busiest year on record is 1995, with 6. The most recent is 2006, with 1.

Clearances by year, as a table
510(k) clearance decisions for COPAN Diagnostics, Inc., by decision year
YearClearances
19956
19991
20011
20041
20061
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K061301COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEMJTWSubstantially Equivalent
K042970COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEMJSMSubstantially Equivalent
K001780COPAN VIRAL TRANSYSTEMJSMSubstantially Equivalent
K993161COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEMJTWSubstantially Equivalent
K946288COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUMJSMSubstantially Equivalent
K946287COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOALJSMSubstantially Equivalent
K946286COPAN VENTURI TRANSYSTEM CARY-BLAIR MEDIUMJSMSubstantially Equivalent
K946285COPAN VENTURI TRANSYSTEM STUARTS MEDIUMJSMSubstantially Equivalent
K946284COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOALJSMSubstantially Equivalent
K946283COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUMJSMSubstantially Equivalent

Registered establishments

FDA registered establishments for COPAN Diagnostics, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
24368751000521444COPAN DIAGNOSTICS, INC.26055, 26083 & 26087 Jefferson Avenue, Murrieta, CA 92562 US2026and 4 more, listed in full below
30170632173017063217COPAN Diagnostics, Inc.2728 Loker Ave. W, Carlsbad, CA 92010 US2026

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

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2620-2023COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.Due to plastic defects, the pipette aspiration capability potentially doesn't meet the expected toleranceClass IIOpen, Classified

Verification record

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