510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831387Substantially Equivalent

Hs-100 Headspace Sampling Accessory

Revvity Health Sciences, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831387 is the FDA 510(k) clearance record for HS-100 HEADSPACE SAMPLING ACCESSORY, a class I device, cleared for The Perkin-Elmer Corp. on under FDA product code KZQ (Chromatography(Gas), Clinical Use). FDA records list 81 510(k) clearances for Revvity Health Sciences, Inc., from to . As of , FDA records show no recalls naming K831387.

Clearance record

Decision date
Received
(118 days to decision)
Product code
KZQ Chromatography(Gas), Clinical Use
Regulation
21 CFR 862.2250
Device class
Class I
Review panel
Clinical Chemistry
Applicant
The Perkin-Elmer Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KZQ

Trailing 12 months

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

FDA records show no clearances under product code KZQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KZQ, 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