Home / 510(k) Clearances / K802821

510(k) K802821

PARAGON HEMOGLOBIN ELECTRO. REAG. KIT by Beckman Instruments, Inc. — Product Code JBD

K802821 is an FDA 510(k) premarket notification submitted by Beckman Instruments, Inc. for the device "PARAGON HEMOGLOBIN ELECTRO. REAG. KIT". The FDA issued a decision of Substantially Equivalent on December 11, 1980. The device falls under product code JBD (System, Analysis, Electrophoretic Hemoglobin), a Class II device regulated under 21 CFR 864.7440. Beckman Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1980
Date Received
November 10, 1980
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 Beckman Instruments, Inc.

  • K973448 — ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, (September 17, 1998)
  • K982250 — ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (July 14, 1998)
  • K981403 — IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT (May 8, 1998)
  • K981354 — ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 (May 1, 1998)
  • K980173 — ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 (March 18, 1998)
  • K974816 — ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 (February 20, 1998)
  • K974564 — IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT (February 17, 1998)
  • K974110 — IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT (December 24, 1997)
  • K974452 — VIGIL LIPID CONTROL (December 17, 1997)
  • K973932 — BECKMAN CALIBRATOR 2 (CAL2) (December 15, 1997)

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)
  • K820518 — GELMAN GLYCO-PHORE BUFFER (April 9, 1982)

FDA data resources