Pylori Igg Elisa Test System
FDA 510(k) K961221 · Armkel, LLC
510(k) numberK961221
Submission
- Device name
- Pylori Igg Elisa Test System
- Applicant
- Armkel, LLC
Frederick, MD, US - Received
- March 20, 1996
- Decision date
- July 30, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LYR – Helicobacter Pylori
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3110
- Specialty
- Microbiology
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| K001212 | Trojan Extra Large Latex CondomHIS · Special | 05/09/2000SE |
| K000748 | Trojan Latex Condom with Male Genital Desensitizer LubricantHIS · Special | 04/06/2000SE |
| K992232 | First Response 1-STEP PregnancyLCX · Traditional | 12/21/1999SE |
| K973352 | Brand Name *1-STEP PregnancyLCX · Traditional | 10/27/1997SE |
| K973310 | Tbd* One-Step Ovulation Predictor TestCEP · Traditional | 10/27/1997SE |
Questions and answers
When was Pylori Igg Elisa Test System cleared by the FDA?
Pylori Igg Elisa Test System (K961221) received a 510(k) decision of Substantially Equivalent on July 30, 1996, 132 days after the submission was received.
What is the product code of K961221?
The FDA product code is LYR – Helicobacter Pylori, a Class I (low risk) device regulated under 21 CFR 866.3110.