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510(k) K832886

FLAME PHOTOMETER T281-T282-T283 by Texas Intl. Laboratories, Inc. — Product Code JJO

K832886 is an FDA 510(k) premarket notification submitted by Texas Intl. Laboratories, Inc. for the device "FLAME PHOTOMETER T281-T282-T283". The FDA issued a decision of Substantially Equivalent on December 8, 1983. The device falls under product code JJO (Flame Emission Photometer For Clinical Use), a Class I device regulated under 21 CFR 862.2540. Texas Intl. Laboratories, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1983
Date Received
August 26, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flame Emission Photometer For Clinical Use
Device Class
Class I
Regulation Number
862.2540
Review Panel
CH
Submission Type

Other clearances by Texas Intl. Laboratories, Inc.

  • K953643 — HEMATIL 18 (H-18) (March 22, 1996)
  • K904031 — CHEMA CHOL CHOLESTEROL SYSTEM (March 11, 1991)
  • K900684 — RDW AND MPV INDICES ON HEMAT 12 (April 16, 1990)
  • K900685 — CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER (April 16, 1990)
  • K884006 — HEMAT 12 (December 5, 1988)
  • K883177 — H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER (November 30, 1988)
  • K853722 — PLT-4 PLATELET ANALYZER (January 17, 1986)
  • K832890 — HEMACOMP 7 OR HEMATIL 7 (October 19, 1983)
  • K831649 — THERMOMIXER S213-PHOTOANALYZER S263 (August 24, 1983)

Other clearances for product code JJO

  • K873603 — FINNIGAN MAT INCOS 50 (September 22, 1987)
  • K862148 — OLYMPUS AU 5000 FLAME PHOTOMETER MODULE (September 29, 1986)
  • K843375 — ELVI 655 FLAME PHOTOMETER (May 20, 1985)
  • K841847 — LITHIUM REAGENT (August 17, 1984)
  • K834226 — FLAME PHOTOMETERS (June 22, 1984)
  • K841421 — DAILY WASH SOLUTION 5 (May 11, 1984)
  • K841422 — VOLUME TEST DYE 6 (May 11, 1984)
  • K840530 — SUPPLIES FOR INSTRUMENTATION LAB FLAME (March 30, 1984)
  • K840044 — SDI PREPAX DILUKIT 29-1000 (March 9, 1984)
  • K833535 — POTASSIUM SODIUM ANALYSIS PRODUCTS (December 29, 1983)

FDA data resources