Home / 510(k) Clearances / K792014

510(k) K792014

LANCER L-INA BUFFER, POLYMER, WASH SOLU by Sherwood Medical Industries — Product Code JZW

K792014 is an FDA 510(k) premarket notification submitted by Sherwood Medical Industries for the device "LANCER L-INA BUFFER, POLYMER, WASH SOLU". The FDA issued a decision of Substantially Equivalent on November 13, 1979. The device falls under product code JZW (Nephelometer), a Class I device regulated under 21 CFR 866.4540. Sherwood Medical Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1979
Date Received
October 5, 1979
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 Sherwood Medical Industries

  • K801070 — SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES (July 21, 1980)
  • K801071 — LANCER GLUCOSE RATE REAGENT KIT (May 23, 1980)
  • K792013 — LANCER L-INA HUMAN REFERENCE SERUM (November 13, 1979)
  • K782077 — LANCER ICE CUBE (April 3, 1979)
  • K790523 — ARGYLE ESOPHAGEAL STETHOSCOPE (March 27, 1979)
  • K790196 — MONOJECT ARTERIAL BLOOD SAMPLING DEVICE (March 13, 1979)
  • K790197 — REAGENT KIT, LANCER GLUCOSE (March 12, 1979)
  • K781459 — MONOJECT SCALE MAGNIFIER (October 24, 1978)
  • K781060 — MONOJECT ENDOSSEOUS DENTAL IMPLANT (August 14, 1978)
  • K772149 — LANCER BIOPSY HOLDER (November 22, 1977)

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)
  • K801949 — BCM-302 COLLIMATING CONE & COMPENSATIN (October 3, 1980)
  • K801391 — DISC 120 TRANSPORTER (July 14, 1980)
  • 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