Maclean-Fogg, Dispos-Inocula-Loops
FDA 510(k) K842057 · Polymer Technology Corp.
510(k) numberK842057
Submission
- Device name
- Maclean-Fogg, Dispos-Inocula-Loops
- Applicant
- Polymer Technology Corp.
Mchenry, IL, US - Received
- May 22, 1984
- Decision date
- June 7, 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 Maclean-Fogg, Dispos-Inocula-Loops cleared by the FDA?
Maclean-Fogg, Dispos-Inocula-Loops (K842057) received a 510(k) decision of Substantially Equivalent on June 7, 1984, 16 days after the submission was received.
What is the product code of K842057?
The FDA product code is LIB – Device, General Purpose, Microbiology, Diagnostic, a Class I (low risk) device regulated under 21 CFR 866.2660.