510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Streck LLC

La Vista, NE, US

STRECK LLC appears in FDA device records in La Vista, NE. FDA records list 38 510(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
38
PMA records
0
Recall records
1
Registered establishments
2

510(k) clearance history

FDA records hold 38 510(k) clearances for Streck LLC between 2005 and 2026. The busiest year on record is 2014, with 5. The most recent is 2026, with 3.

Clearances by year, as a table
510(k) clearance decisions for Streck LLC, by decision year
YearClearances
20052
20063
20071
20082
20094
20101
20113
20124
20145
20164
20171
20201
20221
20232
20241
20263
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K260041MDx-Chex for BCPPMNSubstantially Equivalent
K254166MDx-Chex for BCNPMNSubstantially Equivalent
K254167MDx-Chex for BCYPMNSubstantially Equivalent
K231776Cell-Free DNA BCTQMASubstantially Equivalent
K231223MDx-Chex for BC-GNPMNSubstantially Equivalent
K231221MDx-Chex for BC-GPPMNSubstantially Equivalent
K212576MDx-Chex for BCID2PMNSubstantially Equivalent
DEN200001Cell-Free DNA BCTQMAUnknown
K170091UA-Cellular CompleteJJWSubstantially Equivalent
K160590XN CHECKJPKSubstantially Equivalent
K160588XN CHECK BFJPKSubstantially Equivalent
K160586XN-L CHECKJPKSubstantially Equivalent
K160585XN CALKRXSubstantially Equivalent
K141964XN CHECKJPKSubstantially Equivalent
K141962XN CALKRXSubstantially Equivalent
K141957XN CHECK BFJPKSubstantially Equivalent
K141955XN CAL PFKRXSubstantially Equivalent
K131444UA-CELLULAR COMPLETEJJWSubstantially Equivalent
K120747XN CAL PFKRXSubstantially Equivalent
K120745XN CALKRXSubstantially Equivalent
K120744XN CHECK BFJPKSubstantially Equivalent
K120742XN CHECKJPKSubstantially Equivalent
K111211CELL-DYN 22 PLUS CONTROLGLQSubstantially Equivalent
K111204CELL-DYN 22 PLUS CALIBRATORKRXSubstantially Equivalent
K110718CELL-CHEX WITH CPPD CRYSTALSGLQSubstantially Equivalent
K101335CELL-CHEXGLQSubstantially Equivalent
K090201UA-CELLULAR FOR IQJPKSubstantially Equivalent
K090137STAK-CHEX PLUS RETICSGLQSubstantially Equivalent
K083926CD4 COUNTGGLSubstantially Equivalent
K083200X-CALKRXSubstantially Equivalent
K080552CYTO-CHEX BCTGIMSubstantially Equivalent
K080016NRBC-CHEX FOR ADVIAGJRSubstantially Equivalent
K070199RETIC-CHEX LINEARITY FOR BCJPKSubstantially Equivalent
K063218E-CHECK (XE)JPKSubstantially Equivalent
K060083NRBC-CHEX FOR LHGJRSubstantially Equivalent
K053362CELL-CHEX AUTOJPKSubstantially Equivalent
K051706IQ BODY FLUIDS CONTROLJPKSubstantially Equivalent
K051633CD-CHEX PLUS BCGGLSubstantially Equivalent

Registered establishments

FDA registered establishments for Streck LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
19503021950302STRECK LLC7002 SOUTH 109TH ST., La Vista, NE 68128 US2026and 9 more, listed in full below
30179531513017953151STRECK LLC11710 Peel Circle, La Vista, NE 68128 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-1684-2017Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0ml only. Packaged 6-tube pack REF 213559 and 100-tube box REF 218980. Streck.Complaints of the 2.0ml tube stopper coming loose during phlebotomy when small diameter tube adapters were not utilized. Such adapters aid with centering small diameter tubes to properly pierce the middle of the stoppers.Class IIOpen, Classified

Verification record

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