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510(k) K761234

BEHRING LASER NEPHELOMETER by Behring Diagnostics, Inc. — Product Code JZW

K761234 is an FDA 510(k) premarket notification submitted by Behring Diagnostics, Inc. for the device "BEHRING LASER NEPHELOMETER". The FDA issued a decision of Substantially Equivalent on June 7, 1990. The device falls under product code JZW (Nephelometer), a Class I device regulated under 21 CFR 866.4540. Behring Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1990
Date Received
June 7, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nephelometer
Device Class
Class I
Regulation Number
866.4540
Review Panel
IM
Submission Type

Other clearances by Behring Diagnostics, Inc.

  • K973832 — OPUS HLH CONTROLS (October 27, 1997)
  • K972929 — N ANTISERUM TO HUMAN ALBUMIN (October 20, 1997)
  • K972840 — N ANTISERUM TO HUMAN TRANSFERRIN (October 17, 1997)
  • K973202 — MODIFICATION OF OPUS FERRITIN TEST SYSTEM (September 12, 1997)
  • K972316 — OPUS D-DIMER (September 9, 1997)
  • K972116 — VON WILLEBRAND REAGENT (July 25, 1997)
  • K972011 — OPUS ETHANOL (July 22, 1997)
  • K971600 — EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) (June 25, 1997)
  • K971596 — EMIT II OPIATES 300/2000 ASSAY (June 25, 1997)
  • K964595 — OPUS PSA TEST SYSTEM (June 24, 1997)

Other clearances for product code JZW

  • K001647 — BN PROSPEC SYSTEM (September 26, 2000)
  • K892223 — BEHRING NEPHELOMETER 100 (May 4, 1989)
  • K873401 — TURBOX (September 23, 1987)
  • K873407 — RRT SYSTEM LASER REFLECTOMETER ANALYZER (September 23, 1987)
  • K801949 — BCM-302 COLLIMATING CONE & COMPENSATIN (October 3, 1980)
  • K801391 — DISC 120 TRANSPORTER (July 14, 1980)
  • K792014 — LANCER L-INA BUFFER, POLYMER, WASH SOLU (November 13, 1979)
  • K781006 — IMMUNOCHEMISTRY SYS. MANUAL MODE (August 31, 1978)
  • K761236 — ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR. (December 30, 1976)
  • K761235 — LASER STANDARD SERUM (December 30, 1976)

FDA data resources