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510(k) K821415

MODEL 90 BC by Western Laboratories Corp. — Product Code FLB

K821415 is an FDA 510(k) premarket notification submitted by Western Laboratories Corp. for the device "MODEL 90 BC". The FDA issued a decision of Substantially Equivalent on May 27, 1982. The device falls under product code FLB (Meter, Conductivity, Induction, Remote Type), a Class II device regulated under 21 CFR 876.5820. Western Laboratories Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1982
Date Received
May 12, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Meter, Conductivity, Induction, Remote Type
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Western Laboratories Corp.

  • K834024 — HEPARINOMETER (June 11, 1984)
  • K830468 — MODEL 200 (April 12, 1983)
  • K821834 — MODEL 100 BICARBONATE CONDUCTIVITY (July 2, 1982)
  • K821414 — MODEL 80 BC (May 27, 1982)
  • K801303 — MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TEST (July 28, 1980)
  • K780932 — MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT (August 31, 1978)

Other clearances for product code FLB

  • K100237 — DIALYSATE METER, MODEL D-6 (April 23, 2010)
  • K925210 — 90DX MULTITEST METER, MODIFICATION (January 25, 1994)
  • K882032 — MODEL 90DX MULTITEST METER (August 11, 1988)
  • K830629 — COBE RX METER (April 6, 1983)
  • K770263 — DIALYSATE METER RS-2100A, CIRCUIT CHANGE (February 18, 1977)

FDA data resources