Abbott Testpack(Tm) Gonorrhea Positive Control
FDA 510(k) K882534 · Abbott Laboratories
510(k) numberK882534
Submission
- Device name
- Abbott Testpack(Tm) Gonorrhea Positive Control
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- June 21, 1988
- Decision date
- July 12, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIR – Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3390
- Specialty
- Microbiology
Other 510(k)s with product code LIR
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Questions and answers
When was Abbott Testpack(Tm) Gonorrhea Positive Control cleared by the FDA?
Abbott Testpack(Tm) Gonorrhea Positive Control (K882534) received a 510(k) decision of Substantially Equivalent on July 12, 1988, 21 days after the submission was received.
What is the product code of K882534?
The FDA product code is LIR – Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae, a Class II (moderate risk) device regulated under 21 CFR 866.3390.