Product code KSK— Hematology

FDA has cleared 5 devices under product code KSK between 1976 and 1982, filed by 4 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.

• 19822 clearances
• 19811 clearance
• 19781 clearance
• 19761 clearance

• Biological Corp. of America2 clearances
• Hyland Therapeutic Div., Travenol Laboratories1 clearance
• Gamma Biologicals, Inc.1 clearance
• Bd Becton Dickinson Vacutainer Systems Preanalytic1 clearance

• K813342 — GAMMA CHLOROQUINE DIPHOSPHATE SOLUTIONGamma Biologicals, Inc.·1982-03-04
• K813404 — FREEZE DRIED FICINBiological Corp. of America·1982-02-10
• K810803 — FREEZE DRIED PAPAINBiological Corp. of America·1981-07-21
• K780962 — AUTOMATED ENZYMEHyland Therapeutic Div., Travenol Laboratories·1978-07-27
• K760123 — AUTOZYMEBd Becton Dickinson Vacutainer Systems Preanalytic·1976-07-20