Tandem-E Ferritin Calibration Verification Conrol
FDA 510(k) K921252 · Hybritech, Inc.
510(k) numberK921252
Submission
- Device name
- Tandem-E Ferritin Calibration Verification Conrol
- Applicant
- Hybritech, Inc.
San Diego, CA, US - Received
- March 16, 1992
- Decision date
- July 17, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K972666 | Tandem-Mp Ostase Immunoenzymetric AssayCIN · Traditional | 09/11/1997SE |
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| K921745 | Hybritech Stratus Pap Fluorometric Enzyme ImmunoJFH · Traditional | 07/30/1992SE |
| K920556 | Tandem-E HCG Calibration Verification Control SetJJX · Traditional | 07/17/1992SE |
| K921763 | Tandem Icon QSR CKMB Immunoenzymetric AssayJHY · Traditional | 06/09/1992SE |
| K912439 | Tandem-E TSH Calibration Verification Control SetJJX · Traditional | 08/28/1991SE |
| K911417 | Icon Strep B Immunoenzymetric AssayGTZ · Traditional | 07/24/1991SE |
| K902991 | Icon Strep B Immunoenzymetric AssayGTY · Traditional | 10/03/1990SE |
Questions and answers
When was Tandem-E Ferritin Calibration Verification Conrol cleared by the FDA?
Tandem-E Ferritin Calibration Verification Conrol (K921252) received a 510(k) decision of Substantially Equivalent on July 17, 1992, 123 days after the submission was received.
What is the product code of K921252?
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.