Liquid Immunology Control Level I, II, III
FDA 510(k) K963085 · International Enzymes, Inc.
510(k) numberK963085
Submission
- Device name
- Liquid Immunology Control Level I, II, III
- Applicant
- International Enzymes, Inc.
San Marcos, CA, US - Received
- August 8, 1996
- Decision date
- August 20, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K950802 | Linical Protein I Calibration Verifiers Levels a - for Beckman Array 360 SystemJJY · Traditional | 06/01/1995SE |
| K944513 | Linical Protein Vi Calibration Verifiers Levels A-EJJY · Traditional | 12/02/1994SE |
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Questions and answers
When was Liquid Immunology Control Level I, II, III cleared by the FDA?
Liquid Immunology Control Level I, II, III (K963085) received a 510(k) decision of Substantially Equivalent on August 20, 1996, 12 days after the submission was received.
What is the product code of K963085?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.