Home / 510(k) Clearances / K820518

510(k) K820518

GELMAN GLYCO-PHORE BUFFER by Gelman Sciences, Inc. — Product Code JBD

K820518 is an FDA 510(k) premarket notification submitted by Gelman Sciences, Inc. for the device "GELMAN GLYCO-PHORE BUFFER". The FDA issued a decision of Substantially Equivalent on April 9, 1982. The device falls under product code JBD (System, Analysis, Electrophoretic Hemoglobin), a Class II device regulated under 21 CFR 864.7440. Gelman Sciences, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1982
Date Received
February 25, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Analysis, Electrophoretic Hemoglobin
Device Class
Class II
Regulation Number
864.7440
Review Panel
HE
Submission Type

Other clearances by Gelman Sciences, Inc.

  • K946190 — DRUG DISPENSING SPIKE (March 17, 1995)
  • K943127 — PHARMASSURE LARGE VOLUME TRANSFER FILTERS (September 29, 1994)
  • K941589 — SYRINGE FILTER DEVICES (September 6, 1994)
  • K941020 — DRUG RECONSTITUTION FILTER DEVICE (August 10, 1994)
  • K942275 — VIAL VENT FILTER (July 26, 1994)
  • K941032 — UNKNOWN (May 27, 1994)
  • K910821 — TRANSDUCER PROTECTOR (August 12, 1991)
  • K892387 — MODIFIED GELMAN ARTERIAL FILTER (June 22, 1989)
  • K884176 — CHROMATOGRAPHY KIT (April 4, 1989)
  • K884178 — DRUG CONTROL SET (February 17, 1989)

Other clearances for product code JBD

  • K053571 — MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOB (June 30, 2006)
  • K032862 — INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM (February 3, 2004)
  • K992199 — ACID HEMOGLOBIN KIT (September 21, 1999)
  • K991362 — HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), A (June 21, 1999)
  • K982426 — SPIFE ALKALINE HEMOGLOBIN (December 17, 1998)
  • K931503 — REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) (August 16, 1993)
  • K931465 — REP ALKALINE HB-15 #3196,-8 #3197,-4 3198 (July 6, 1993)
  • K901143 — REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) (May 23, 1990)
  • K830804 — LABILE REMOVING HEMOLYZING REAGENT (May 4, 1983)
  • K813395 — CELLULOSE ACETATE-CITRATE AGAR HEMOGLO (December 31, 1981)

FDA data resources