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510(k) K803050

SPRAY, SYNTHETIC SMEAR by Laboratory Products, Inc. — Product Code IFI

K803050 is an FDA 510(k) premarket notification submitted by Laboratory Products, Inc. for the device "SPRAY, SYNTHETIC SMEAR". The FDA issued a decision of Substantially Equivalent on December 30, 1980. The device falls under product code IFI (Sprays, Synthetic, Smear), a Class I device regulated under 21 CFR 864.4010. Laboratory Products, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1980
Date Received
December 2, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sprays, Synthetic, Smear
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

Other clearances by Laboratory Products, Inc.

  • K832588 — CIN AGAR (September 12, 1983)
  • K803051 — FLAME PHOTOMETRY REAGENTS (January 9, 1981)
  • K803013 — CHLORIDE/TCO2 ANALYZER REAGENTS (January 2, 1981)
  • K800180 — VARIOUS REAGENTS FOR BLOOD CELL ANALYZER (March 19, 1980)
  • K792482 — CHEMISTRY ANALYZER REAGENTS (January 11, 1980)
  • K792481 — CULTURE PLATES & TUBED MEDIA (December 31, 1979)
  • K792483 — STAINS, COUNTERSTAINS & GEN. PURPOSE (December 18, 1979)

FDA data resources