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510(k) K001647

BN PROSPEC SYSTEM by Dade Behring, Inc. — Product Code JZW

K001647 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "BN PROSPEC SYSTEM". The FDA issued a decision of Substantially Equivalent on September 26, 2000. The device falls under product code JZW (Nephelometer), a Class I device regulated under 21 CFR 866.4540. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2000
Date Received
May 30, 2000
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 Dade Behring, Inc.

  • K093848 — PT-MULTI-CALIBRATOR, MODEL OPAT07 (December 20, 2010)
  • K081161 — DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEI (July 28, 2008)
  • K081249 — DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROT (July 21, 2008)
  • K071603 — DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) (June 25, 2008)
  • K071597 — DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (June 4, 2008)
  • K073604 — DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CAR (March 13, 2008)
  • K073561 — DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA (February 26, 2008)
  • K073072 — DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B (February 21, 2008)
  • K073055 — DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 (January 3, 2008)
  • K072965 — DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON (December 21, 2007)

Other clearances for product code JZW

  • K761234 — BEHRING LASER NEPHELOMETER (June 7, 1990)
  • K892223 — BEHRING NEPHELOMETER 100 (May 4, 1989)
  • K873407 — RRT SYSTEM LASER REFLECTOMETER ANALYZER (September 23, 1987)
  • K873401 — TURBOX (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