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510(k) K800754

NICKERSON'S MED. SELECTIVE CULTURE MEDIU by Ortho Pharmaceutical Corp. — Product Code JSJ

K800754 is an FDA 510(k) premarket notification submitted by Ortho Pharmaceutical Corp. for the device "NICKERSON'S MED. SELECTIVE CULTURE MEDIU". The FDA issued a decision of Substantially Equivalent on April 29, 1980. The device falls under product code JSJ (Culture Media, Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2360. Ortho Pharmaceutical Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1980
Date Received
April 4, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Selective And Non-Differential
Device Class
Class I
Regulation Number
866.2360
Review Panel
MI
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)
  • K881151 — MICROSCRAPE (April 6, 1988)
  • K810581 — FACT* HOME PREGNANCY TEST (March 17, 1981)
  • K792634 — CONCEPTROL/THIN PROPHYLACTICS (January 16, 1980)
  • K790087 — LUBRICANT, OTRHO PERSONAL (February 1, 1979)

Other clearances for product code JSJ

  • K882463 — POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 (June 22, 1988)
  • K881570 — SABOURAUD MALTOSE AGAR (April 18, 1988)
  • K881524 — DERMATOPHYTE TEST MEDIUM (April 18, 1988)
  • K881544 — LITTMAN AGAR (April 18, 1988)
  • K881571 — YM BROTH (April 18, 1988)
  • K881547 — MITIS SALIVARIUS AGAR (April 18, 1988)
  • K881565 — INHIBITORY MOLD AGAR (April 18, 1988)
  • K881573 — PHYTONE YEAST EXTRACT AGAR (April 18, 1988)
  • K881526 — CHAPMAN STONE MEDIUM (April 18, 1988)
  • K881561 — TERGITOL 7 BROTH (April 18, 1988)

FDA data resources