Microbio. Prod. Fluorescent Antibody
FDA 510(k) K770801 · Pfizer Pharmaceuticals
510(k) numberK770801
Submission
- Device name
- Microbio. Prod. Fluorescent Antibody
- Applicant
- Pfizer Pharmaceuticals
Mchenry, IL, US - Received
- May 2, 1977
- Decision date
- May 25, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GMY – Antisera, Fluorescent, All Types, Escherichia Coli
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3255
- Specialty
- Microbiology
Other 510(k)s with product code GMY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K770833 | Fluoretec-MGMY · Traditional | Pfizer, Inc. | 06/08/1977SE |
More from Pfizer, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K885321 | Water Jel Sterile Gel-Soaked Burn DressingFRO · Traditional | 03/22/1989SN |
| K810427 | Cefotaxime 30MCG Antimicrobial Suscep.JTN · Traditional | 03/31/1981SE |
| K802408 | E-Vac Blood Culture SystemJSC · Traditional | 10/23/1980SE |
| K771605 | Creatine Kinase Isoenzyme Substrate SetJHX · Traditional | 09/15/1977SE |
| K770425 | Needles, Sterile, AirwayFMI · Traditional | 04/15/1977SE |
Questions and answers
When was Microbio. Prod. Fluorescent Antibody cleared by the FDA?
Microbio. Prod. Fluorescent Antibody (K770801) received a 510(k) decision of Substantially Equivalent on May 25, 1977, 23 days after the submission was received.
What is the product code of K770801?
The FDA product code is GMY – Antisera, Fluorescent, All Types, Escherichia Coli, a Class I (low risk) device regulated under 21 CFR 866.3255.