Product code GJR— Hematology

FDA has cleared 5 devices under product code GJR between 1990 and 2008, filed by 3 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.

• 20081 clearance
• 20061 clearance
• 20001 clearance
• 19951 clearance
• 19901 clearance

• Streck Laboratories, Inc.2 clearances
• Streck2 clearances
• Medical Specialties Intl., Inc.1 clearance

• K080016 — NRBC-CHEX FOR ADVIAStreck·2008-02-05
• K060083 — NRBC-CHEX FOR LHStreck·2006-02-09
• K000076 — CELL-CHEXStreck Laboratories, Inc.·2000-03-03
• K940430 — SEDRATROLMedical Specialties Intl., Inc.·1995-02-06
• K900484 — RET-CHECKStreck Laboratories, Inc.·1990-03-09