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510(k) K842863

PRO-SOFT DEHYDRANT by Anatech, Ltd. — Product Code PPM

K842863 is an FDA 510(k) premarket notification submitted by Anatech, Ltd. for the device "PRO-SOFT DEHYDRANT". The FDA issued a decision of Substantially Equivalent on August 21, 1984. The device falls under product code PPM (General Purpose Reagent), a Class I device regulated under 21 CFR 864.4010. Anatech, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1984
Date Received
July 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
General Purpose Reagent
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test.

Other clearances by Anatech, Ltd.

  • K882874 — ZINC FORMALIN (July 28, 1988)
  • K882873 — FIELDTEX HEMATOXYLIN (July 28, 1988)
  • K882268 — ZINC FORMALIN CONCENTRATE (June 15, 1988)
  • K881282 — XYLENE (April 5, 1988)
  • K872663 — DRY-FORM (August 6, 1987)
  • K872498 — HARRIS HEMATOXYLIN (July 9, 1987)
  • K872500 — ANATECH HEMATOXYLIN-EXTRA STRENGTH (July 9, 1987)
  • K872499 — ANATECH HEMATOXYLIN-NORMAL STRENGTH (July 9, 1987)
  • K870852 — NBF 10% NEUTRAL BUFFERED FORMALIN (March 31, 1987)
  • K842940 — CBA FORMALIN (August 28, 1984)

Other clearances for product code PPM

  • K871533 — TOMTEC GRAM STAINER DECOLORIZER (April 29, 1987)
  • K863550 — POTASSIUM HYDROXIDE 10% W/V (October 2, 1986)
  • K861890 — 100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2 (June 3, 1986)
  • K850916 — SPRAYFIX (March 25, 1985)
  • K850737 — TRANSPORT CULTURE MEDIUM (March 20, 1985)
  • K850845 — 0.85% SALINE (March 20, 1985)
  • K842934 — DECOLORIZING FLUIC, ACID-ALCOHOL 3% (September 12, 1984)
  • K842729 — DECOLORIZING FLUID (August 3, 1984)
  • K842070 — IDD DETERGENT (July 2, 1984)
  • K831620 — SODIUM HYPOCHLORITE 3% (July 28, 1983)

FDA data resources