Spray, Synthetic Smear

FDA 510(k) K803050 · Laboratory Products, Inc.

Substantially Equivalent

510(k) numberK803050

Submission

Device name
Spray, Synthetic Smear
Applicant
Laboratory Products, Inc.
Mchenry, IL, US
Received
December 2, 1980
Decision date
December 30, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IFI – Sprays, Synthetic, Smear
Device class
Class I (low risk)
Regulation
21 CFR 864.4010
Specialty
Pathology

More from Laboratory Products, Inc.

510(k)DeviceDecision
K832588Cin AgarJSJ · Traditional 09/12/1983SE
K803051Flame Photometry ReagentsJIX · Traditional 01/09/1981SE
K803013CHLORIDE/TCO2 Analyzer ReagentsCHJ · Traditional 01/02/1981SE
K800180Various Reagents for Blood Cell AnalyzerGIF · Traditional 03/19/1980SE
K792482Chemistry Analyzer ReagentsCIX · Traditional 01/11/1980SE
K792481Culture Plates & Tubed MediaJTZ · Traditional 12/31/1979SE
K792483Stains, Counterstains & Gen. PurposeICL · Traditional 12/18/1979SE

Questions and answers

When was Spray, Synthetic Smear cleared by the FDA?

Spray, Synthetic Smear (K803050) received a 510(k) decision of Substantially Equivalent on December 30, 1980, 28 days after the submission was received.

What is the product code of K803050?

The FDA product code is IFI – Sprays, Synthetic, Smear, a Class I (low risk) device regulated under 21 CFR 864.4010.