Company ยท US
Streck Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2004. Name variants (Inc, Corp, punctuation) are merged.
70510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JPK | Mixture, Hematology Quality Control | 23 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 9 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 7 |
| GGL | Control, White-Cell | 4 |
| GLQ | Mixture, Control, White-Cell And Red-Cell Indices | 4 |
| JCN | Control, Cell Counter, Normal And Abnormal | 4 |
| GHM | Test, Sickle Cell | 2 |
| GJR | Control, Red-Cell | 2 |
| KRX | Calibrator For Cell Indices | 2 |
| KRY | Calibrator For Platelet Counting | 2 |
| GKL | Counter, Cell, Automated (Particle Counter) | 1 |
| GLG | Platelet Counting, Manual | 1 |
| JBX | Aggregrometer, Platelet | 1 |
| JIS | Calibrator, Primary | 1 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 |
| JOX | Analyzer, Heparin, Automated | 1 |
| JRR | Regulator, Temperature | 1 |
| KRZ | Calibrator For Hemoglobin And Hematocrit Measurement | 1 |
| KSA | Calibrator For Red-Cell And White-Cell Counting | 1 |
| LAW | Theophylline Control Materials | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 19, 2004 | K042587 | RETIC-CHEX FOR CELL-DYN Streck Laboratories, Inc. | JPK |
| Jul 27, 2004 | K040107 | CYTO-CHEX BCT Streck Laboratories, Inc. | JKA |
| Mar 2, 2004 | K040025 | A1C-CELLULAR Streck Laboratories, Inc. | JJX |
| Dec 30, 2002 | K023656 | SICKLE-CHEX SOLUBILITY KIT Streck Laboratories, Inc. | GHM |
| Jun 25, 2002 | K021922 | MODIFICATION TO PARA 5X Streck Laboratories, Inc. | JPK |
| Apr 4, 2002 | K020469 | CAL-CHEX CD PLUS Streck Laboratories, Inc. | KRX |
| Nov 6, 2001 | K013316 | SICKLE-CHEX Streck Laboratories, Inc. | GHM |
| Jun 26, 2001 | K011410 | PARA 5X Streck Laboratories, Inc. | JPK |
| Jun 29, 2000 | K001443 | SUGAR CHEX ONE Streck Laboratories, Inc. | JJX |
| Apr 18, 2000 | K000945 | PARA 12 PLUS RETICS Streck Laboratories, Inc. | GLQ |
| Mar 27, 2000 | K000115 | RETIC CHEX LINEARITY Streck Laboratories, Inc. | JPK |
| Mar 3, 2000 | K000076 | CELL-CHEX Streck Laboratories, Inc. | GJR |
| Jan 14, 2000 | K994388 | XE CHECK Streck Laboratories, Inc. | GLQ |
| Nov 30, 1999 | K993825 | PARA TECH PLUS RETICS Streck Laboratories, Inc. | JCN |
| Nov 26, 1999 | K993126 | CD-CHEX CD 34 Streck Laboratories, Inc. | GGL |
| Nov 22, 1999 | K992887 | STAK-CHEX PLUS RETICS Streck Laboratories, Inc. | GLQ |
| Jul 22, 1998 | K982290 | CHEM-CHEX STAT (NEW) Streck Laboratories, Inc. | JJY |
| May 24, 1996 | K960894 | CD-CHEX + RBC Streck Laboratories, Inc. | GGL |
| May 15, 1996 | K961195 | CHEM-CHEX STAT Streck Laboratories, Inc. | JJY |
| Apr 3, 1996 | K960557 | CALIBRATION VERIFICATION ASSESSMENT (CVA) Streck Laboratories, Inc. | JPK |
| Sep 1, 1995 | K952245 | SF-CHECK Streck Laboratories, Inc. | JPK |
| Dec 15, 1994 | K943268 | SCS-1000 (SYSMEX CALIBRATOR SYSTEM) Streck Laboratories, Inc. | KSA |
| Sep 9, 1994 | K942632 | TNT TROPONIN T Streck Laboratories, Inc. | JJX |
| Jun 6, 1994 | K931825 | CD-CHEX CD4 LOW Streck Laboratories, Inc. | GGL |
| Apr 5, 1994 | K935196 | PARA 5 DIFF Streck Laboratories, Inc. | JPK |
| Mar 9, 1994 | K940181 | SE-CHECK Streck Laboratories, Inc. | JPK |
| Dec 27, 1993 | K933844 | PARA 4 PLUS Streck Laboratories, Inc. | JJY |
| Jan 28, 1993 | K925479 | SUGAR CHEX LINEARITY FOR THE ONE TOUCH Streck Laboratories, Inc. | JJX |
| Nov 16, 1992 | K923971 | QC-CHEX Streck Laboratories, Inc. | JPK |
| Jun 10, 1992 | K920223 | CHEM CHEX THEOPHYLLINE CONTROL Streck Laboratories, Inc. | LAW |
| May 31, 1992 | K920997 | CD-CHEX Streck Laboratories, Inc. | GGL |
| Mar 23, 1992 | K920350 | CHEM-CHEM MULTI-ANALYTE (MODIFIED) Streck Laboratories, Inc. | JJY |
| Sep 19, 1991 | K913687 | CHEM-CHEX Streck Laboratories, Inc. | JJY |
| May 28, 1991 | K911582 | STAK-CHEX Streck Laboratories, Inc. | JCN |
| Feb 20, 1991 | K905524 | RETIC-CHEX Streck Laboratories, Inc. | JPK |
| Dec 26, 1990 | K905389 | CHEM-CHEX LIPID Streck Laboratories, Inc. | JJY |
| Aug 9, 1990 | K903147 | CHEM-CHEX-ALT Streck Laboratories, Inc. | JJX |
| Jul 16, 1990 | K902867 | CHEM-CHEX BILIRUBIN Streck Laboratories, Inc. | JJX |
| May 30, 1990 | K901875 | PARA 12 PLUS Streck Laboratories, Inc. | JCN |
| Apr 16, 1990 | K900993 | CHEM-CHEX Streck Laboratories, Inc. | JJY |
| Mar 9, 1990 | K900484 | RET-CHECK Streck Laboratories, Inc. | GJR |
| Nov 9, 1989 | K896154 | PARA TECH FOR TECHNICON H-1 Streck Laboratories, Inc. | JCN |
| Mar 23, 1989 | K890767 | NE-CHECK Streck Laboratories, Inc. | JPK |
| Jul 1, 1988 | K881829 | PAT PLATELET AGGREGATION TEST Streck Laboratories, Inc. | JBX |
| Sep 16, 1987 | K873105 | REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL Streck Laboratories, Inc. | JJX |
| Oct 10, 1985 | K852992 | PARA CHECK (AKA EIGHT CHECK-C) Streck Laboratories, Inc. | JPK |
| Jul 5, 1985 | K852107 | SICKLE-CHEX Streck Laboratories, Inc. | |
| Apr 29, 1985 | K851043 | SUGAR-CHEX II Streck Laboratories, Inc. | JJX |
| Apr 29, 1985 | K851042 | SUGAR-CHEX Streck Laboratories, Inc. | JJX |
| Oct 23, 1984 | K843093 | RETIC-CHEX Streck Laboratories, Inc. | JPK |
Newest 50 of 70.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||