Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Streck Laboratories, Inc. — Predicate Candidate Screening
70 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
143 days90th percentile
70clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K042587 | RETIC-CHEX FOR CELL-DYN | Streck Laboratories, Inc. | 2004-10-19 | 27 | 0 |
| K040107 | CYTO-CHEX BCT | Streck Laboratories, Inc. | 2004-07-27 | 189 | 0 |
| K040025 | A1C-CELLULAR | Streck Laboratories, Inc. | 2004-03-02 | 55 | 0 |
| K023656 | SICKLE-CHEX SOLUBILITY KIT | Streck Laboratories, Inc. | 2002-12-30 | 61 | 0 |
| K021922 | MODIFICATION TO PARA 5X | Streck Laboratories, Inc. | 2002-06-25 | 14 | 0 |
| K020469 | CAL-CHEX CD PLUS | Streck Laboratories, Inc. | 2002-04-04 | 51 | 0 |
| K013316 | SICKLE-CHEX | Streck Laboratories, Inc. | 2001-11-06 | 33 | 0 |
| K011410 | PARA 5X | Streck Laboratories, Inc. | 2001-06-26 | 49 | 0 |
| K001443 | SUGAR CHEX ONE | Streck Laboratories, Inc. | 2000-06-29 | 52 | 0 |
| K000945 | PARA 12 PLUS RETICS | Streck Laboratories, Inc. | 2000-04-18 | 26 | 0 |
| K000115 | RETIC CHEX LINEARITY | Streck Laboratories, Inc. | 2000-03-27 | 73 | 0 |
| K000076 | CELL-CHEX | Streck Laboratories, Inc. | 2000-03-03 | 53 | 0 |
| K994388 | XE CHECK | Streck Laboratories, Inc. | 2000-01-14 | 17 | 0 |
| K993825 | PARA TECH PLUS RETICS | Streck Laboratories, Inc. | 1999-11-30 | 18 | 3 |
| K993126 | CD-CHEX CD 34 | Streck Laboratories, Inc. | 1999-11-26 | 67 | 0 |
| K992887 | STAK-CHEX PLUS RETICS | Streck Laboratories, Inc. | 1999-11-22 | 87 | 0 |
| K982290 | CHEM-CHEX STAT (NEW) | Streck Laboratories, Inc. | 1998-07-22 | 23 | 0 |
| K960894 | CD-CHEX + RBC | Streck Laboratories, Inc. | 1996-05-24 | 80 | 0 |
| K961195 | CHEM-CHEX STAT | Streck Laboratories, Inc. | 1996-05-15 | 49 | 0 |
| K960557 | CALIBRATION VERIFICATION ASSESSMENT (CVA) | Streck Laboratories, Inc. | 1996-04-03 | 54 | 0 |
| K952245 | SF-CHECK | Streck Laboratories, Inc. | 1995-09-01 | 112 | 0 |
| K943268 | SCS-1000 (SYSMEX CALIBRATOR SYSTEM) | Streck Laboratories, Inc. | 1994-12-15 | 161 | 0 |
| K942632 | TNT TROPONIN T | Streck Laboratories, Inc. | 1994-09-09 | 98 | 0 |
| K931825 | CD-CHEX CD4 LOW | Streck Laboratories, Inc. | 1994-06-06 | 426 | 0 |
| K935196 | PARA 5 DIFF | Streck Laboratories, Inc. | 1994-04-05 | 161 | 0 |
| K940181 | SE-CHECK | Streck Laboratories, Inc. | 1994-03-09 | 56 | 0 |
| K933844 | PARA 4 PLUS | Streck Laboratories, Inc. | 1993-12-27 | 143 | 0 |
| K925479 | SUGAR CHEX LINEARITY FOR THE ONE TOUCH | Streck Laboratories, Inc. | 1993-01-28 | 147 | 0 |
| K923971 | QC-CHEX | Streck Laboratories, Inc. | 1992-11-16 | 102 | 0 |
| K920223 | CHEM CHEX THEOPHYLLINE CONTROL | Streck Laboratories, Inc. | 1992-06-10 | 145 | 0 |
| K920997 | CD-CHEX | Streck Laboratories, Inc. | 1992-05-31 | 90 | 0 |
| K920350 | CHEM-CHEM MULTI-ANALYTE (MODIFIED) | Streck Laboratories, Inc. | 1992-03-23 | 59 | 0 |
| K913687 | CHEM-CHEX | Streck Laboratories, Inc. | 1991-09-19 | 31 | 5 |
| K911582 | STAK-CHEX | Streck Laboratories, Inc. | 1991-05-28 | 50 | 0 |
| K905524 | RETIC-CHEX | Streck Laboratories, Inc. | 1991-02-20 | 72 | 0 |
| K905389 | CHEM-CHEX LIPID | Streck Laboratories, Inc. | 1990-12-26 | 26 | 0 |
| K903147 | CHEM-CHEX-ALT | Streck Laboratories, Inc. | 1990-08-09 | 22 | 0 |
| K902867 | CHEM-CHEX BILIRUBIN | Streck Laboratories, Inc. | 1990-07-16 | 17 | 0 |
| K901875 | PARA 12 PLUS | Streck Laboratories, Inc. | 1990-05-30 | 34 | 0 |
| K900993 | CHEM-CHEX | Streck Laboratories, Inc. | 1990-04-16 | 45 | 0 |
| K900484 | RET-CHECK | Streck Laboratories, Inc. | 1990-03-09 | 36 | 0 |
| K896154 | PARA TECH FOR TECHNICON H-1 | Streck Laboratories, Inc. | 1989-11-09 | 16 | 0 |
| K890767 | NE-CHECK | Streck Laboratories, Inc. | 1989-03-23 | 36 | 0 |
| K881829 | PAT PLATELET AGGREGATION TEST | Streck Laboratories, Inc. | 1988-07-01 | 63 | 0 |
| K873105 | REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL | Streck Laboratories, Inc. | 1987-09-16 | 40 | 0 |
| K852992 | PARA CHECK (AKA EIGHT CHECK-C) | Streck Laboratories, Inc. | 1985-10-10 | 87 | 0 |
| K852107 | SICKLE-CHEX | Streck Laboratories, Inc. | 1985-07-05 | 51 | 0 |
| K851043 | SUGAR-CHEX II | Streck Laboratories, Inc. | 1985-04-29 | 46 | 0 |
| K851042 | SUGAR-CHEX | Streck Laboratories, Inc. | 1985-04-29 | 46 | 0 |
| K843093 | RETIC-CHEX | Streck Laboratories, Inc. | 1984-10-23 | 77 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda