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510(k) K883062

ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID by Alpha-Tec Systems, Inc. — Product Code LDW

K883062 is an FDA 510(k) premarket notification submitted by Alpha-Tec Systems, Inc. for the device "ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID". The FDA issued a decision of Substantially Equivalent on August 4, 1988. The device falls under product code LDW (Fixative, Acid 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 4, 1988
Date Received
July 19, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fixative, Acid 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)
  • K883048 — ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION (August 17, 1988)
  • K883049 — ATS PARA-SET IODINE ALCOHOL SOLUTION (August 17, 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 LDW

  • K842923 — PICRIC ACID 1% W/V (September 11, 1984)
  • K842922 — PICRIC ACID SATURATED SOLUTION (September 7, 1984)
  • K831058 — SAF FIXATIVE (June 8, 1983)

FDA data resources