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510(k) K830130

MINIATURE ION SELECTIVE ELECTRODES by Ionetics, Inc. — Product Code JSG

K830130 is an FDA 510(k) premarket notification submitted by Ionetics, Inc. for the device "MINIATURE ION SELECTIVE ELECTRODES". The FDA issued a decision of Substantially Equivalent on March 7, 1983. The device falls under product code JSG (Culture Media, Non-Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2300. Ionetics, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1983
Date Received
January 11, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Selective And Non-Differential
Device Class
Class I
Regulation Number
866.2300
Review Panel
MI
Submission Type

Other clearances by Ionetics, Inc.

  • K932179 — MODEL 400/450 ELECTROLYTE ANALYZER (November 17, 1993)
  • K895397 — CALCIUM AND PH ELECTROLYTE ANALYZER (December 12, 1989)
  • K890792 — POTASSIUM AND SODIUM ELECTROLYTE ANALYZER (May 3, 1989)
  • K863907 — MODIFIED SODIUM ELECTRODE (December 10, 1986)
  • K851808 — ELECTROLYTE ANALYZER (June 25, 1985)
  • K802856 — MINIATURE ION SELECTIVE ELECTRODES (January 28, 1981)

Other clearances for product code JSG

  • K882495 — THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 (July 1, 1988)
  • K881542 — HEART INFUSION AGAR (April 18, 1988)
  • K881550 — OF BASAL MEDIUM (April 18, 1988)
  • K881563 — TRYPTOSE PHOSPHATE BROTH (April 18, 1988)
  • K881548 — MPH AGAR (April 18, 1988)
  • K881528 — CASEIN PEPTONE, LOW VITAMIN (April 18, 1988)
  • K881531 — BLOOD AGAR BASE, IMPROVED (April 18, 1988)
  • K881523 — DEXTROSE TRYPTONE BROTH (April 18, 1988)
  • K881558 — TRYPTOSE AGAR (April 18, 1988)
  • K881541 — GELATIN (April 18, 1988)

FDA data resources