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510(k) K803054

SAF FIXATIVE by Remel Co. — Product Code IGB

K803054 is an FDA 510(k) premarket notification submitted by Remel Co. for the device "SAF FIXATIVE". The FDA issued a decision of Substantially Equivalent on December 22, 1980. The device falls under product code IGB (Solution, Formalin-Sodium Acetate), a Class I device regulated under 21 CFR 864.4010. Remel Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1980
Date Received
December 2, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solution, Formalin-Sodium Acetate
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

Other clearances by Remel Co.

  • K162620 — Remel Spectra ESBL (May 1, 2017)
  • K131804 — REMEL XPECT FLU A&B (July 12, 2013)
  • K092407 — REMEL SPECTRA MRSA (October 8, 2010)
  • K072827 — RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE (November 26, 2007)
  • K041951 — XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B (November 15, 2004)
  • K033479 — PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY (February 26, 2004)
  • K031942 — XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 (November 18, 2003)
  • K031965 — XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 (November 14, 2003)
  • K031834 — XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY (November 10, 2003)
  • K031565 — XPECT INFLUENZA A/B (July 17, 2003)

FDA data resources