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

Omaha, NE, US

Streck Laboratories, Inc. appears in FDA device records in Omaha, NE. FDA records list 70 510(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
70
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 70

FDA records hold 70 510(k) clearances for Streck Laboratories, Inc. between 1977 and 2004. The busiest year on record is 1990, with 6. The most recent is 2004, with 3.

Clearances by year, as a table
510(k) clearance decisions for Streck Laboratories, Inc., by decision year
YearClearances
19772
19784
19794
19803
19811
19822
19831
19844
19854
19871
19881
19892
19906
19913
19924
19932
19945
19951
19963
19981
19993
20005
20012
20023
20043
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K042587RETIC-CHEX FOR CELL-DYNJPKSubstantially Equivalent
K040107CYTO-CHEX BCTJKASubstantially Equivalent
K040025A1C-CELLULARJJXSubstantially Equivalent
K023656SICKLE-CHEX SOLUBILITY KITGHMSubstantially Equivalent
K021922MODIFICATION TO PARA 5XJPKSubstantially Equivalent
K020469CAL-CHEX CD PLUSKRXSubstantially Equivalent
K013316SICKLE-CHEXGHMSubstantially Equivalent
K011410PARA 5XJPKSubstantially Equivalent
K001443SUGAR CHEX ONEJJXSubstantially Equivalent
K000945PARA 12 PLUS RETICSGLQSubstantially Equivalent
K000115RETIC CHEX LINEARITYJPKSubstantially Equivalent
K000076CELL-CHEXGJRSubstantially Equivalent
K994388XE CHECKGLQSubstantially Equivalent
K993825PARA TECH PLUS RETICSJCNSubstantially Equivalent
K993126CD-CHEX CD 34GGLSubstantially Equivalent
K992887STAK-CHEX PLUS RETICSGLQSubstantially Equivalent
K982290CHEM-CHEX STAT (NEW)JJYSubstantially Equivalent
K960894CD-CHEX + RBCGGLSubstantially Equivalent
K961195CHEM-CHEX STATJJYSubstantially Equivalent
K960557CALIBRATION VERIFICATION ASSESSMENT (CVA)JPKSubstantially Equivalent
K952245SF-CHECKJPKSubstantially Equivalent
K943268SCS-1000 (SYSMEX CALIBRATOR SYSTEM)KSASubstantially Equivalent
K942632TNT TROPONIN TJJXSubstantially Equivalent
K931825CD-CHEX CD4 LOWGGLSubstantially Equivalent
K935196PARA 5 DIFFJPKSubstantially Equivalent
K940181SE-CHECKJPKSubstantially Equivalent
K933844PARA 4 PLUSJJYSubstantially Equivalent
K925479SUGAR CHEX LINEARITY FOR THE ONE TOUCHJJXSubstantially Equivalent
K923971QC-CHEXJPKSubstantially Equivalent
K920223CHEM CHEX THEOPHYLLINE CONTROLLAWSubstantially Equivalent
K920997CD-CHEXGGLSubstantially Equivalent
K920350CHEM-CHEM MULTI-ANALYTE (MODIFIED)JJYSubstantially Equivalent
K913687CHEM-CHEXJJYSubstantially Equivalent
K911582STAK-CHEXJCNSubstantially Equivalent
K905524RETIC-CHEXJPKSubstantially Equivalent
K905389CHEM-CHEX LIPIDJJYSubstantially Equivalent
K903147CHEM-CHEX-ALTJJXSubstantially Equivalent
K902867CHEM-CHEX BILIRUBINJJXSubstantially Equivalent
K901875PARA 12 PLUSJCNSubstantially Equivalent
K900993CHEM-CHEXJJYSubstantially Equivalent
K900484RET-CHECKGJRSubstantially Equivalent
K896154PARA TECH FOR TECHNICON H-1JCNSubstantially Equivalent
K890767NE-CHECKJPKSubstantially Equivalent
K881829PAT PLATELET AGGREGATION TESTJBXSubstantially Equivalent
K873105REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROLJJXSubstantially Equivalent
K852992PARA CHECK (AKA EIGHT CHECK-C)JPKSubstantially Equivalent
K852107SICKLE-CHEXSubstantially Equivalent
K851043SUGAR-CHEX IIJJXSubstantially Equivalent
K851042SUGAR-CHEXJJXSubstantially Equivalent
K843093RETIC-CHEXJPKSubstantially 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.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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