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510(k) K770774

LYTETEK SYSTEM by Boehringer Mannheim Corp. — Product Code JGT

K770774 is an FDA 510(k) premarket notification submitted by Boehringer Mannheim Corp. for the device "LYTETEK SYSTEM". The FDA issued a decision of Substantially Equivalent on July 11, 1977. The device falls under product code JGT (Flame Photometry, Sodium), a Class II device regulated under 21 CFR 862.1665. Boehringer Mannheim Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1977
Date Received
April 28, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flame Photometry, Sodium
Device Class
Class II
Regulation Number
862.1665
Review Panel
CH
Submission Type

Other clearances by Boehringer Mannheim Corp.

  • K984326 — ELECYS IGE ASSAY (February 8, 1999)
  • K983047 — ACCU-CHEK HQ SYSTEM (February 5, 1999)
  • K984419 — ELECSYS IGE CALCHECK (February 2, 1999)
  • K984425 — MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR (January 20, 1999)
  • K984372 — ELECSYS CALCHECK TROPONIN T (December 14, 1998)
  • K984105 — ELECSYS TROPONIN T STAT TEST (December 8, 1998)
  • K983503 — ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT (December 1, 1998)
  • K983469 — PRECISET SERUM PROTEINS CALIBRATOR (November 25, 1998)
  • K983185 — BOEHRINGER MANNHEIM TINA-QUANT IGE TEST (November 12, 1998)
  • K982948 — ELECSYS PSA, MODEL # ELECSYS 1010 (October 27, 1998)

Other clearances for product code JGT

  • K896829 — TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD) (February 23, 1990)
  • K891574 — LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030 (June 9, 1989)
  • K841610 — COMPONENTS FOR POTASSIUM, SODIUM CHLO (May 25, 1984)
  • K840216 — SODIUM/POTASSIUM REAGENT SYS (March 19, 1984)
  • K834248 — PARALLEL FLAME PHOTOMETER & SODIUM (January 30, 1984)
  • K811886 — CESIUM DILUENT 7.5M (July 23, 1981)
  • K801892 — KLINAR REAGENT PAK, #36010 (October 23, 1980)

FDA data resources