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510(k) K781323

LDH PROCEDURE by Analytical & Research Chemicals, Inc.

K781323 is an FDA 510(k) premarket notification submitted by Analytical & Research Chemicals, Inc. for the device "LDH PROCEDURE". The FDA issued a decision of Substantially Equivalent on August 31, 1978. Analytical & Research Chemicals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1978
Date Received
July 31, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Analytical & Research Chemicals, Inc.

  • K823806 — DIRECT CREATININE PROCEDURE (January 14, 1983)
  • K823786 — ALKALINE PHOSPHATASE (January 14, 1983)
  • K823784 — ENZYMATIC CHOLESTEROL (COLORIMETRIC (January 14, 1983)
  • K781441 — BCG ALBUMIN REAGET (October 10, 1978)
  • K781460 — CHLORIDE REAGENT (October 10, 1978)
  • K781306 — UREA NITROGEN TEST KIT (August 31, 1978)
  • K781309 — GOT PROCEDURE (August 31, 1978)
  • K781305 — UREA NITROGEN (August 31, 1978)
  • K781307 — GLUCOSE DETERM. KIT (August 31, 1978)
  • K781308 — GLUCOLOUR (August 31, 1978)

FDA data resources