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510(k) K810762

API TURBICITY STANDARD by Analytical Products, Inc. — Product Code JKP

K810762 is an FDA 510(k) premarket notification submitted by Analytical Products, Inc. for the device "API TURBICITY STANDARD". The FDA issued a decision of Substantially Equivalent on April 3, 1981. The device falls under product code JKP (Chromium-51, Blood Volume), a Class I device regulated under 21 CFR 862.1130. Analytical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1981
Date Received
March 23, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromium-51, Blood Volume
Device Class
Class I
Regulation Number
862.1130
Review Panel
CH
Submission Type

Other clearances by Analytical Products, Inc.

  • K924814 — API 20E/UNISCEPT 20E (March 11, 1993)
  • K923684 — API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC (December 3, 1992)
  • K922926 — API UNISCEPT KB/TYPE 2 AND 3 (October 13, 1992)
  • K901559 — MODIFICATION TO API UNISCEPT 20GP (September 10, 1990)
  • K901390 — DMAC INDOLE REAGENT (April 16, 1990)
  • K895796 — API UNISCEPT KB (November 13, 1989)
  • K884510 — MODIFICATION MICRO-MIC (November 22, 1988)
  • K884509 — MODIFICATION MIC/API UNISCEPT(R) (November 22, 1988)
  • K880598 — MODIFICATIONS TO API UNISCEPT (R) KB (March 23, 1988)
  • K874466 — API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC (December 9, 1987)

FDA data resources