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510(k) K873407

RRT SYSTEM LASER REFLECTOMETER ANALYZER by Incstar Corp. — Product Code JZW

K873407 is an FDA 510(k) premarket notification submitted by Incstar Corp. for the device "RRT SYSTEM LASER REFLECTOMETER ANALYZER". The FDA issued a decision of Substantially Equivalent on September 23, 1987. The device falls under product code JZW (Nephelometer), a Class I device regulated under 21 CFR 866.4540. Incstar Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1987
Date Received
August 25, 1987
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 Incstar Corp.

  • K963289 — INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY (May 1, 1997)
  • K963296 — INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565) (December 16, 1996)
  • K963297 — INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560) (December 16, 1996)
  • K960367 — INCSTAR RUBELLA IGG ELISA ASSAY (October 24, 1996)
  • K960358 — INCSTAR RUBELLA IGG FAST ELISA ASSAY (October 24, 1996)
  • K960434 — INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530 (October 17, 1996)
  • K953567 — INCSTAR 25-HYDROXYVITMIN D 1251 RIA (September 25, 1996)
  • K955362 — INCSTAR HSV I/II IGG FAST ELISA ASSAY (July 24, 1996)
  • K955363 — INCSTAR HSZ I/II IGG ELISA ASSAY (July 24, 1996)
  • K955361 — INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY (July 22, 1996)

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)
  • 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