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510(k) K873407

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

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

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  • K873401 — TURBOX (September 23, 1987)
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  • 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)
  • K761235 — LASER STANDARD SERUM (December 30, 1976)
  • K761236 — ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR. (December 30, 1976)