Company ยท US
Wescor, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 2013. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 27, 2013 | K121823 | CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC Wescor, Inc. | JFS |
| Mar 20, 2001 | K010031 | NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM Wescor, Inc. | KTB |
| May 24, 1988 | K863395 | WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER Wescor, Inc. | CGZ |
| May 13, 1988 | K881592 | WESCOR MODEL 7300 AEROSPRAY GRAM STAINER Wescor, Inc. | KPA |
| Apr 18, 1988 | K881512 | WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY Wescor, Inc. | JTS |
| Apr 1, 1988 | K880544 | WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY Wescor, Inc. | GJL |
| Oct 16, 1985 | K853973 | WESCOR MODEL 3700 WEBSTER SWEAT INDUCER Wescor, Inc. | KTB |
| Mar 30, 1984 | K834214 | WESCOR 5500 VAPOR PRESSURE OSMOMETER Wescor, Inc. | JJM |
| Mar 23, 1984 | K834208 | COLLOID OSMOMETER 4400 Wescor, Inc. | JJM |
| Mar 19, 1984 | K840472 | SYS MACRODUCT SWEAT COLLECTION SYS 3600 Wescor, Inc. | KTB |
| Oct 31, 1983 | K833295 | WESCOR 7100 AEROSPRAY SLIDE STAINER Wescor, Inc. | KPA |
| Oct 31, 1983 | K830429 | WEIL PERFUSOMETER #100 Wescor, Inc. | FLL |
| Oct 28, 1983 | K833260 | STAIN PACK FOR AEROSPRAY SLIDE STAINER Wescor, Inc. | IAF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 9, 2010 | Wescor, Inc SS-H2O Aerospray Deionized Water, 500 mL, IVD, Wescor, Inc, Logan, Utah 84321. Terminated |
HYB | None listed |
| Mar 9, 2010 | Wescor, Inc SS-035CG, Hematology Reagent C Eosin Stain, 1 U.S. Gallon, IVD, Wescor, Inc, Logan, Utah 84321.
Specifically for use on the Wescor 7120 Hematology Aerospray Slide Stainer and is intended for use by m Terminated |
HYB | None listed |
| Mar 9, 2010 | Wescor, Inc SS-035C, Hematology Reagent C Eosin Stain, 500 mL, IVD,
Wescor, Inc, Logan, Utah 84321.
Specifically for use on the Wescor 7120 Hematology Aerospray Slide Stainer and is intended for use by medical Terminated |
HYB | None listed |
| Mar 27, 2008 | Wescor, Inc Osmocoll, COP Control Reference, SS-038, Contents: 6 unit packages of 1 mL vials (3 each High and Low), Wescor, Inc., 459 South Main Street, Logan, Utah 84321. Terminated |
JJM | K834208 |
| Mar 27, 2008 | Wescor, Inc Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials (Normal), Manufactured for Wescor, Inc., 459 South Main Street, Logan, Utah 84321. Terminated |
JJM | K834208 |