Giardia Guard
FDA 510(k) K842052 · Gelman Sciences, Inc.
510(k) numberK842052
Submission
- Device name
- Giardia Guard
- Applicant
- Gelman Sciences, Inc.
Mchenry, IL, US - Received
- May 22, 1984
- Decision date
- September 11, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIB – Device, General Purpose, Microbiology, Diagnostic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
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Questions and answers
When was Giardia Guard cleared by the FDA?
Giardia Guard (K842052) received a 510(k) decision of Substantially Equivalent on September 11, 1984, 112 days after the submission was received.
What is the product code of K842052?
The FDA product code is LIB – Device, General Purpose, Microbiology, Diagnostic, a Class I (low risk) device regulated under 21 CFR 866.2660.