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510(k) K881151

MICROSCRAPE by Ortho Pharmaceutical Corp. — Product Code LXK

K881151 is an FDA 510(k) premarket notification submitted by Ortho Pharmaceutical Corp. for the device "MICROSCRAPE". The FDA issued a decision of Substantially Equivalent on April 6, 1988. The device falls under product code LXK (Scrapper, Skin Specimen), a Class I device regulated under 21 CFR 878.4800. Ortho Pharmaceutical Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1988
Date Received
March 17, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scrapper, Skin Specimen
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Ortho Pharmaceutical Corp.

  • K955648 — K-Y PERSONAL LUBRICANT (June 21, 1996)
  • K934516 — ADVANCE PREGNANCY TEST MODIFICATION (February 24, 1994)
  • K914990 — ADVANCE(R) PREGNANCY TEST (December 23, 1991)
  • K893488 — PULSATILE PUMP FOR GONADORELIN ACETATE (October 31, 1989)
  • K810581 — FACT* HOME PREGNANCY TEST (March 17, 1981)
  • K800754 — NICKERSON'S MED. SELECTIVE CULTURE MEDIU (April 29, 1980)
  • K792634 — CONCEPTROL/THIN PROPHYLACTICS (January 16, 1980)
  • K790087 — LUBRICANT, OTRHO PERSONAL (February 1, 1979)

FDA data resources