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510(k) K792196

8 SUBJECT PHOTOVOLT ELECTROLYTE SERUM CO by Photovolt Corp. — Product Code JJR

K792196 is an FDA 510(k) premarket notification submitted by Photovolt Corp. for the device "8 SUBJECT PHOTOVOLT ELECTROLYTE SERUM CO". The FDA issued a decision of Substantially Equivalent on November 13, 1979. The device falls under product code JJR (Electrolyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Photovolt Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1979
Date Received
November 1, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrolyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Photovolt Corp.

  • K800453 — PHOTOVOLT PVA 4M+2 ANALYZER (March 20, 1980)

Other clearances for product code JJR

  • K990971 — EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816 (April 27, 1999)
  • K960592 — ELECTROLYTE STANDARDS (May 13, 1996)
  • K955630 — RNA MEDICAL HEMAT CONTROL (March 1, 1996)
  • K951435 — AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL (May 2, 1995)
  • K943925 — SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING (October 4, 1994)
  • K934641 — I-STAT CONTROL LEVELS 1,2,3 (December 9, 1993)
  • K912513 — ELECTROLYTE CONTROL (July 19, 1991)
  • K902266 — ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED) (June 6, 1990)
  • K894576 — CIBA CORNING CERTAIN LYTE (October 30, 1989)
  • K895582 — QCLYTE PROTEIN-BASED ISE CONTROL (October 4, 1989)

FDA data resources