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510(k) K870988

PRICE'S ACID-FAST STAIN by Devetec, Inc. — Product Code JTS

K870988 is an FDA 510(k) premarket notification submitted by Devetec, Inc. for the device "PRICE'S ACID-FAST STAIN". The FDA issued a decision of Substantially Equivalent on March 30, 1987. The device falls under product code JTS (Stains, Microbiologic), a Class I device regulated under 21 CFR 864.1850. Devetec, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1987
Date Received
March 11, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stains, Microbiologic
Device Class
Class I
Regulation Number
864.1850
Review Panel
MI
Submission Type

Other clearances by Devetec, Inc.

  • K894045 — MODIFIED POLYCHROME IV STAIN (July 25, 1989)
  • K873594 — TIF FECAL TEST (September 29, 1987)
  • K854176 — POLYCHROME IV STAIN (October 31, 1985)

Other clearances for product code JTS

  • K960090 — CALCOFLUOR WHITE STAIN KIT (March 19, 1996)
  • K960095 — BACTIDROP CALCOFLUOR WHITE (March 19, 1996)
  • K920976 — BACTIDROP INDIA INK (June 9, 1992)
  • K920970 — BACTIDROP KOH (10%) (June 9, 1992)
  • K920975 — BACTIDROP CALCOFLUOR WHITE (June 9, 1992)
  • K893530 — IRISTAIN FORMULA 2, PARTS 1 AND 2 (June 13, 1989)
  • K890861 — ATS DOBELL & O'CONNOR'S IODINE (March 23, 1989)
  • K890020 — ATS LUGOL'S IODINE SOLUTION (February 24, 1989)
  • K884069 — SNAP N' STAIN IODINE STAIN (October 25, 1988)
  • K883052 — METHENO-STAIN KIT (August 30, 1988)

FDA data resources