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510(k) K925703

OPUS SEROLOGY CONTROLS by Pb Diagnostics, Inc. — Product Code MJX

K925703 is an FDA 510(k) premarket notification submitted by Pb Diagnostics, Inc. for the device "OPUS SEROLOGY CONTROLS". The FDA issued a decision of Substantially Equivalent on April 8, 1993. The device falls under product code MJX (Kit, Serological, Positive Control), a Class I device regulated under 21 CFR 862.1660. Pb Diagnostics, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1993
Date Received
November 12, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Serological, Positive Control
Device Class
Class I
Regulation Number
862.1660
Review Panel
MI
Submission Type

Other clearances by Pb Diagnostics, Inc.

  • K921523 — OPUS(R) TOXO-G TEST SYSTEM (September 14, 1992)
  • K915870 — OPUS RUBELLA TEST SYSTEM (March 23, 1992)
  • K913080 — OPUS(R) ANTI CMV-M (October 28, 1991)

Other clearances for product code MJX

  • K101434 — AUDIT MICROCV PROCALCITONIN LINEARITY (July 22, 2010)
  • K030067 — VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS (January 17, 2003)
  • K974262 — SYSCOS IDC - G, IDC, BSC, IDC - G (December 24, 1997)
  • K972986 — ACCURUN 140 RUBELLA IGG POSITIVE CONTROL (October 8, 1997)
  • K970100 — TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SER (March 10, 1997)
  • K934137 — OPUS(R) SEROLOGY CONTROLS, MODIFICATION (March 7, 1994)

FDA data resources