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510(k) K883048

ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION by Alpha-Tec Systems, Inc. — Product Code LDZ

K883048 is an FDA 510(k) premarket notification submitted by Alpha-Tec Systems, Inc. for the device "ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION". The FDA issued a decision of Substantially Equivalent on August 17, 1988. The device falls under product code LDZ (Fixative, Alcohol Containing), a Class I device regulated under 21 CFR 864.4010. Alpha-Tec Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1988
Date Received
July 16, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fixative, Alcohol Containing
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

Other clearances by Alpha-Tec Systems, Inc.

  • K053257 — PARA-PRO FC50 (May 12, 2006)
  • K890861 — ATS DOBELL & O'CONNOR'S IODINE (March 23, 1989)
  • K890020 — ATS LUGOL'S IODINE SOLUTION (February 24, 1989)
  • K890148 — ATS TB RAPID STAIN SET PRODUCT #034-45 (January 24, 1989)
  • K890022 — ATS MAYER'S ALBUMIN (January 10, 1989)
  • K883049 — ATS PARA-SET IODINE ALCOHOL SOLUTION (August 17, 1988)
  • K883062 — ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID (August 4, 1988)
  • K881949 — ATS NAC-PAC SET (May 25, 1988)
  • K881698 — ATS PVA FIXATIVE SOLUTION (May 13, 1988)
  • K880989 — ATS CRYPTOSPORIDIUM STAIN SET (May 13, 1988)

Other clearances for product code LDZ

  • K881922 — CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE (May 25, 1988)
  • K881698 — ATS PVA FIXATIVE SOLUTION (May 13, 1988)
  • K862725 — SACCOMANNO SPECIMAN SOLUTION (August 1, 1986)
  • K843428 — BIOFIX (September 27, 1984)
  • K842913 — WRIGHT STAIN FIXATIVE (September 7, 1984)
  • K831061 — PVA FIXATIVE/FORMALIN (June 8, 1983)
  • K761138 — FA TISSUE FIXATIVE & WASH SET (January 6, 1978)

FDA data resources