510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970483Substantially Equivalent

Aqualite Intact Pth

Sealite Sciences, Inc., Norcross GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970483 is the FDA 510(k) clearance record for AQUALITE INTACT PTH, a class II device, cleared for Sealite Sciences, Inc. on under FDA product code CEW (Radioimmunoassay, Parathyroid Hormone). FDA records list 11 510(k) clearances for Sealite Sciences, Inc., from to . As of , FDA records show no recalls naming K970483.

Clearance record

Decision date
Received
(63 days to decision)
Product code
CEW Radioimmunoassay, Parathyroid Hormone
Regulation
21 CFR 862.1545
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Sealite Sciences, Inc. 3000 Northwoods Pkwy., #200, Norcross GA
510(k) summary
Summary
Third party review
No

Clearances, product code CEW

Trailing 12 months

FDA records hold no clearances under product code CEW in the trailing twelve months.

FDA records show no clearances under product code CEW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CEW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260