Home / 510(k) Clearances / K831058

510(k) K831058

SAF FIXATIVE by American Micro Scan — Product Code LDW

K831058 is an FDA 510(k) premarket notification submitted by American Micro Scan for the device "SAF FIXATIVE". The FDA issued a decision of Substantially Equivalent on June 8, 1983. The device falls under product code LDW (Fixative, Acid Containing), a Class I device regulated under 21 CFR 864.4010. American Micro Scan has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1983
Date Received
April 1, 1983
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 American Micro Scan

  • K864662 — CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS (March 25, 1987)
  • K870029 — IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE (March 25, 1987)
  • K863776 — MICRODILUTION MIC PANELS (February 2, 1987)
  • K864674 — MICRODILUTION IDENTIFICATION PANELS (January 5, 1987)
  • K864389 — CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST (December 4, 1986)
  • K863038 — GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL (September 30, 1986)
  • K862642 — GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL (September 11, 1986)
  • K862332 — ANAEROBE RAPID CHROMOGENIC ID PANEL (August 27, 1986)
  • K862140 — MICRODILUTION PANELS (July 16, 1986)
  • K861584 — GRAM NEGATIVE COMBO PANEL TYPE 3 (June 17, 1986)

Other clearances for product code LDW

  • K883062 — ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID (August 4, 1988)
  • K842923 — PICRIC ACID 1% W/V (September 11, 1984)
  • K842922 — PICRIC ACID SATURATED SOLUTION (September 7, 1984)

FDA data resources