Hybritech 405-500 NM Filter Module
FDA 510(k) K832397 · Hybritech, Inc.
510(k) numberK832397
Submission
- Device name
- Hybritech 405-500 NM Filter Module
- Applicant
- Hybritech, Inc.
Mchenry, IL, US - Received
- July 20, 1983
- Decision date
- August 31, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2300
- Specialty
- Clinical Chemistry
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Questions and answers
When was Hybritech 405-500 NM Filter Module cleared by the FDA?
Hybritech 405-500 NM Filter Module (K832397) received a 510(k) decision of Substantially Equivalent on August 31, 1983, 42 days after the submission was received.
What is the product code of K832397?
The FDA product code is JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2300.