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510(k) K934137

OPUS(R) SEROLOGY CONTROLS, MODIFICATION by Pb Diagnostic Systems, Inc. — Product Code MJX

K934137 is an FDA 510(k) premarket notification submitted by Pb Diagnostic Systems, Inc. for the device "OPUS(R) SEROLOGY CONTROLS, MODIFICATION". The FDA issued a decision of Substantially Equivalent on March 7, 1994. The device falls under product code MJX (Kit, Serological, Positive Control), a Class I device regulated under 21 CFR 862.1660. Pb Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1994
Date Received
August 25, 1993
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 Diagnostic Systems, Inc.

  • K940507 — OPUS FT4 TEST SYSTEM (July 28, 1994)
  • K934762 — OPUS PROCAINAMIDE TEST SYSTEM (July 20, 1994)
  • K933389 — OPUS CMV-G (June 28, 1994)
  • K935229 — OPUS DIGITOXIN (December 22, 1993)
  • K934705 — OPUS NAPA (November 22, 1993)
  • K933066 — OPUS ESTRADIOL (September 8, 1993)
  • K933675 — OPUS TOTAL CK (September 8, 1993)
  • K932279 — OPUS(R) TOTAL B-HCG TEST SYSTEM (July 8, 1993)
  • K926131 — OPUS MAGNUM ANALYZER (June 7, 1993)
  • K924957 — OPUS(R) VANCOMYCIN (December 11, 1992)

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)
  • K925703 — OPUS SEROLOGY CONTROLS (April 8, 1993)

FDA data resources