Product code KSG— Hematology

FDA has cleared 13 devices under product code KSG between 1978 and 1981, filed by 10 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.

• 19812 clearances
• 19802 clearances
• 19795 clearances
• 19784 clearances

• Biological Corp. of America3 clearances
• Ortho Diagnostics, Inc.2 clearances
• Pfizer, Inc.1 clearance
• Miles Laboratories, Inc.1 clearance
• Hyland Therapeutic Div., Travenol Laboratories1 clearance
• Gotham Biologics, Inc.1 clearance
• Gamma Biologicals, Inc.1 clearance
• Fisher Scientific Co., LLC1 clearance
• Dade, Baxter Travenol Diagnostics, Inc.1 clearance
• Bd Becton Dickinson Vacutainer Systems Preanalytic1 clearance

• K812565 — ELUTION SOLUTIONBiological Corp. of America·1981-10-23
• K812222 — EM-XBiological Corp. of America·1981-09-23
• K800943 — PENTEX BOVINE ALBUMIN 30% SOLUTIONMiles Laboratories, Inc.·1980-05-08
• K800189 — BOVINE ALBUMIN 22% & 30% SOLUTIONSGotham Biologics, Inc.·1980-02-13
• K791791 — ORTHO ANTIBODY ENHANCEMENT SOLUTIONOrtho Diagnostics, Inc.·1979-10-11
• K791113 — LOW IONIC STRENGTH SOLUTION (LISS)Hyland Therapeutic Div., Travenol Laboratories·1979-06-28
• K790973 — LO-IONGamma Biologicals, Inc.·1979-06-15
• K790776 — DADE LOW IONIC STRENGTH SOLUITION (LISS)Dade, Baxter Travenol Diagnostics, Inc.·1979-05-23
• K790498 — LISS REAGENTFisher Scientific Co., LLC·1979-04-03
• K781397 — EM-VBiological Corp. of America·1978-09-14
• K781435 — ORTHO LOW IONIC SOLUTIONOrtho Diagnostics, Inc.·1978-09-14
• K780413 — LOW IIONIC STRENGTH SOLUTIONPfizer, Inc.·1978-04-24
• K780556 — SPECT RIM (LISS)Bd Becton Dickinson Vacutainer Systems Preanalytic·1978-04-24