Product code GHS— Hematology

FDA has cleared 5 devices under product code GHS between 1977 and 1998, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19981 clearance
• 19911 clearance
• 19791 clearance
• 19772 clearances

• The London Co.1 clearance
• Radiometer America, Inc.1 clearance
• Natus Medical, Inc.1 clearance
• Iadec, Inc.1 clearance
• Corning Medical & Scientific1 clearance

• K974805 — CO-STAT(TM) END TIDAL BREATH ANALYZERNatus Medical, Inc.·1998-03-11
• K910827 — ABL520 BLOOD GAS SYSTEMRadiometer America, Inc.·1991-07-09
• K790943 — TRISEDTA-BORATE ELECTROPHORESIS FILM AGACorning Medical & Scientific·1979-06-22
• K771263 — RADIOMHTER OSM-2 HEMOXIMETERThe London Co.·1977-08-03
• K770209 — ECOLYZER CARBOXIMETERIadec, Inc.·1977-03-07