Bactigen Group B Streptococcus-Cs Test
FDA 510(k) K872114 · Armkel, LLC
510(k) numberK872114
Submission
- Device name
- Bactigen Group B Streptococcus-Cs Test
- Applicant
- Armkel, LLC
Cranbury, NJ, US - Received
- June 1, 1987
- Decision date
- August 27, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GTZ – Antisera, All Groups, Streptococcus Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3740
- Specialty
- Microbiology
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| K962296 | Streptolex-StatGTZ · Traditional | Unipath , Ltd. | 12/16/1996SE |
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Questions and answers
When was Bactigen Group B Streptococcus-Cs Test cleared by the FDA?
Bactigen Group B Streptococcus-Cs Test (K872114) received a 510(k) decision of Substantially Equivalent on August 27, 1987, 87 days after the submission was received.
What is the product code of K872114?
The FDA product code is GTZ – Antisera, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.