Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

70 results for "Streck Laboratories, Inc."
1–24 of 70
Search insights Median review: 49d Cleared: 100% Top manufacturer: Streck Laboratories, Inc. Lead specialty: Hematology
Cleared Oct 19, 2004
RETIC-CHEX FOR CELL-DYN
K042587 · JPK
Streck Laboratories, Inc.
Hematology · 27d
Cleared Jul 27, 2004
CYTO-CHEX BCT
K040107 · JKA
Streck Laboratories, Inc.
Hematology · 189d
Cleared Mar 02, 2004
A1C-CELLULAR
K040025 · JJX
Streck Laboratories, Inc.
Chemistry · 55d
Cleared Dec 30, 2002
SICKLE-CHEX SOLUBILITY KIT
K023656 · GHM
Streck Laboratories, Inc.
Hematology · 61d
Cleared Jun 25, 2002
MODIFICATION TO PARA 5X
K021922 · JPK
Streck Laboratories, Inc.
Hematology · 14d
Cleared Apr 04, 2002
CAL-CHEX CD PLUS
K020469 · KRX
Streck Laboratories, Inc.
Hematology · 51d
Cleared Nov 06, 2001
SICKLE-CHEX
K013316 · GHM
Streck Laboratories, Inc.
Hematology · 33d
Cleared Jun 26, 2001
PARA 5X
K011410 · JPK
Streck Laboratories, Inc.
Hematology · 49d
Cleared Jun 29, 2000
SUGAR CHEX ONE
K001443 · JJX
Streck Laboratories, Inc.
Chemistry · 52d
Cleared Apr 18, 2000
PARA 12 PLUS RETICS
K000945 · GLQ
Streck Laboratories, Inc.
Hematology · 26d
Cleared Mar 27, 2000
RETIC CHEX LINEARITY
K000115 · JPK
Streck Laboratories, Inc.
Hematology · 73d
Cleared Mar 03, 2000
CELL-CHEX
K000076 · GJR
Streck Laboratories, Inc.
Hematology · 53d
Cleared Jan 14, 2000
XE CHECK
K994388 · GLQ
Streck Laboratories, Inc.
Hematology · 17d
Cleared Nov 30, 1999
PARA TECH PLUS RETICS
K993825 · JCN
Streck Laboratories, Inc.
Hematology · 18d
Cleared Nov 26, 1999
CD-CHEX CD 34
K993126 · GGL
Streck Laboratories, Inc.
Hematology · 67d
Cleared Nov 22, 1999
STAK-CHEX PLUS RETICS
K992887 · GLQ
Streck Laboratories, Inc.
Hematology · 87d
Cleared Jul 22, 1998
CHEM-CHEX STAT (NEW)
K982290 · JJY
Streck Laboratories, Inc.
Chemistry · 23d
Cleared May 24, 1996
CD-CHEX + RBC
K960894 · GGL
Streck Laboratories, Inc.
Hematology · 80d
Cleared May 15, 1996
CHEM-CHEX STAT
K961195 · JJY
Streck Laboratories, Inc.
Chemistry · 49d
Cleared Apr 03, 1996
CALIBRATION VERIFICATION ASSESSMENT (CVA)
K960557 · JPK
Streck Laboratories, Inc.
Hematology · 54d
Cleared Sep 01, 1995
SF-CHECK
K952245 · JPK
Streck Laboratories, Inc.
Hematology · 112d
Cleared Dec 15, 1994
SCS-1000 (SYSMEX CALIBRATOR SYSTEM)
K943268 · KSA
Streck Laboratories, Inc.
Hematology · 161d
Cleared Sep 09, 1994
TNT TROPONIN T
K942632 · JJX
Streck Laboratories, Inc.
Immunology · 98d
Cleared Jun 06, 1994
CD-CHEX CD4 LOW
K931825 · GGL
Streck Laboratories, Inc.
Hematology · 426d