Modification to Prospect Cryptosporidium Microtiter Assay

FDA 510(k) K982709 · Alexon - Trend, Inc.

Substantially Equivalent

510(k) numberK982709

Submission

Device name
Modification to Prospect Cryptosporidium Microtiter Assay
Applicant
Alexon - Trend, Inc.
Ramsey, MN, US
Received
August 4, 1998
Decision date
September 3, 1998
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
MHJ – Cryptosporidium Spp.
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3220
Specialty
Microbiology

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K982764Premier CryptosporidiumMHJ · Traditional Meridian Diagnostics, Inc.12/03/1998SE
K980354Cryptosporidium TestMHJ · Traditional Techlab, Inc.05/18/1998SE
K955852Crypto-Cel If TestMHJ · Traditional Techlab, Inc.08/05/1996SE
K955755Trend Cryptosporidium Detection Test SystemsMHJ · Traditional Trend Scientific, Inc.07/11/1996SE

More from Trend Scientific, Inc.

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K982315Prospect Campylobacter Microplate AssayLQP · Traditional 11/18/1998SE
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Questions and answers

When was Modification to Prospect Cryptosporidium Microtiter Assay cleared by the FDA?

Modification to Prospect Cryptosporidium Microtiter Assay (K982709) received a 510(k) decision of Substantially Equivalent on September 3, 1998, 30 days after the submission was received.

What is the product code of K982709?

The FDA product code is MHJ – Cryptosporidium Spp., a Class II (moderate risk) device regulated under 21 CFR 866.3220.