Cali-Pipette
FDA 510(k) K820346 · Carr-Scarborough Microbiologicals, Inc.
510(k) numberK820346
Submission
- Device name
- Cali-Pipette
- Applicant
- Carr-Scarborough Microbiologicals, Inc.
Mchenry, IL, US - Received
- February 8, 1982
- Decision date
- March 4, 1982
- 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 Cali-Pipette cleared by the FDA?
Cali-Pipette (K820346) received a 510(k) decision of Substantially Equivalent on March 4, 1982, 24 days after the submission was received.
What is the product code of K820346?
The FDA product code is LIB – Device, General Purpose, Microbiology, Diagnostic, a Class I (low risk) device regulated under 21 CFR 866.2660.