Streptococcus Pneumoniae Control
FDA 510(k) K840512 · Scientific Device Laboratory, Inc.
510(k) numberK840512
Submission
- Device name
- Streptococcus Pneumoniae Control
- Applicant
- Scientific Device Laboratory, Inc.
Mchenry, IL, US - Received
- February 6, 1984
- Decision date
- March 23, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GTY – Antigens, All Groups, Streptococcus Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3740
- Specialty
- Microbiology
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| K884069 | Snap N' Stain Iodine StainJTS · Traditional | 10/25/1988SE |
| K884011 | Snap N' Stain Iron StainGGH · Traditional | 10/06/1988SE |
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Questions and answers
When was Streptococcus Pneumoniae Control cleared by the FDA?
Streptococcus Pneumoniae Control (K840512) received a 510(k) decision of Substantially Equivalent on March 23, 1984, 46 days after the submission was received.
What is the product code of K840512?
The FDA product code is GTY – Antigens, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.