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510(k) K801949

BCM-302 COLLIMATING CONE & COMPENSATIN by B C Medical , Ltd. — Product Code JZW

K801949 is an FDA 510(k) premarket notification submitted by B C Medical , Ltd. for the device "BCM-302 COLLIMATING CONE & COMPENSATIN". The FDA issued a decision of Substantially Equivalent on October 3, 1980. The device falls under product code JZW (Nephelometer), a Class I device regulated under 21 CFR 866.4540. B C Medical , Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1980
Date Received
August 15, 1980
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 B C Medical , Ltd.

  • K946378 — BCM 400CP (May 4, 1995)
  • K933100 — ARC-600 (November 8, 1993)
  • K933035 — BCM-600TX (October 8, 1993)
  • K920862 — BCM-400C (September 30, 1992)
  • K890306 — BCM-ARC 105 X-RAY MOBILE UNIT (April 17, 1989)
  • K870205 — ROTAX-II BI-PLANE CIRCULAR ARM (March 6, 1987)
  • K801950 — BCM-600 MINI-SIX EXTRA LG. FIELD ANGIO (October 3, 1980)

Other clearances for product code JZW

  • K001647 — BN PROSPEC SYSTEM (September 26, 2000)
  • K761234 — BEHRING LASER NEPHELOMETER (June 7, 1990)
  • K892223 — BEHRING NEPHELOMETER 100 (May 4, 1989)
  • K873401 — TURBOX (September 23, 1987)
  • K873407 — RRT SYSTEM LASER REFLECTOMETER ANALYZER (September 23, 1987)
  • 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