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510(k) K860795

SPOTTEST CALCOFLUOR WHITE REAGENT by Difco Laboratories, Inc. — Product Code LED

K860795 is an FDA 510(k) premarket notification submitted by Difco Laboratories, Inc. for the device "SPOTTEST CALCOFLUOR WHITE REAGENT". The FDA issued a decision of Substantially Equivalent on March 12, 1986. The device falls under product code LED (Stains, Chemical Solution), a Class I device regulated under 21 CFR 864.1850. Difco Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1986
Date Received
March 4, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stains, Chemical Solution
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

Other clearances by Difco Laboratories, Inc.

  • K971120 — DISPENS-O-DISC (TM) LEVOFLOXACIN (April 14, 1997)
  • K971211 — DISPENS-O-DISC SPARFLOXACIN (April 14, 1997)
  • K963508 — DISPENS-O-DISC MEROPENEM (September 26, 1996)
  • K961148 — CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG) (April 26, 1996)
  • K954783 — DRYSLIDE CARTARRHALIS (February 6, 1996)
  • K954784 — DRYSIDE NEISSERIA (January 30, 1996)
  • K953129 — ESP CULTURE SYSTEM - MYCO (December 26, 1995)
  • K950706 — DRYSLIDE COAGULASE (May 16, 1995)
  • K944275 — DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG. (December 19, 1994)
  • K941016 — DISPENS-O-DISC(TM) NITROCEFIN (June 30, 1994)

Other clearances for product code LED

  • K051409 — SLIVASURE (August 8, 2005)
  • K023046 — SST SALIVA SUPPORTING TABLETS (December 2, 2002)
  • K860319 — MEGACOLOR (February 20, 1986)
  • K860320 — GRANULOCOLOR (February 20, 1986)
  • K860317 — NEUTROCOLOR (February 20, 1986)
  • K860321 — LYSOCOLOR (February 20, 1986)
  • K860316 — PANOPTIKON (February 20, 1986)
  • K854176 — POLYCHROME IV STAIN (October 31, 1985)
  • K851481 — SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR (April 29, 1985)
  • K842930 — GOMORI'S TRICHROME STAIN (September 11, 1984)

FDA data resources