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510(k) K761248

ELECTROPHORESIS ACCESSORY MO. 3526 by Gilford Instrument Laboratories, Inc. — Product Code JJN

K761248 is an FDA 510(k) premarket notification submitted by Gilford Instrument Laboratories, Inc. for the device "ELECTROPHORESIS ACCESSORY MO. 3526". The FDA issued a decision of Substantially Equivalent on December 21, 1976. The device falls under product code JJN (Apparatus, Electrophoresis, For Clinical Use), a Class I device regulated under 21 CFR 862.2485. Gilford Instrument Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1976
Date Received
December 13, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Electrophoresis, For Clinical Use
Device Class
Class I
Regulation Number
862.2485
Review Panel
CH
Submission Type

Other clearances by Gilford Instrument Laboratories, Inc.

  • K823233 — SBA 300 CLINICAL CHEMISTRY ANALYZER (November 29, 1982)
  • K821583 — AMES/GILFORD OPTIMATE CLIN. CHEM & THER (June 24, 1982)
  • K802609 — CHEMISTRY ANALYZER IMPACT 400 (November 26, 1980)
  • K801889 — MODEL 203S CLINICAL CHEMISTRY ANALYZER (September 26, 1980)
  • K800085 — SYSTEM 203 CHEMISTRY ANALYZER (February 13, 1980)
  • K792361 — SYSTEM 103 CHEMISTRY ANALYZER (December 27, 1979)
  • K792087 — MICROFLAME PHOTOMETER (November 13, 1979)
  • K791968 — EIA (ELISA) READER (October 17, 1979)
  • K790072 — ANALYZER, IMPACT 200 (February 22, 1979)
  • K790073 — ANALYZER, IMPACT 100 (February 22, 1979)

Other clearances for product code JJN

  • K924021 — POWER SUPPLY (January 28, 1993)
  • K924020 — ELECTROPHORESIS TANK (December 28, 1992)
  • K882344 — ELECTR-TRANSBLOTTER (January 13, 1989)
  • K881852 — REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170 (July 8, 1988)
  • K882163 — HELENA REP GEL PROCESSOR (June 20, 1988)
  • K873352 — RAPID ELECTROPHORESIS SYSTEM (REP) (September 8, 1987)
  • K864436 — STAVIP 3000 (March 16, 1987)
  • K861414 — ELECTROPHORESIS WORK CENTER (EWC) (August 26, 1986)
  • K841407 — ISOGEL AGAROSE (July 16, 1985)
  • K844710 — EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD (January 7, 1985)

FDA data resources