Atlas FDA

LHT

13 FDA 510(k) clearances · Product code

20 daysmedian time to decision
35 days90th percentile
13clearances measured

FDA profile

Official device name
Staphylococcus Aureus Somatic Antigens
Device class
Class I (low risk)
Regulation
21 CFR 866.3700
Medical specialty
Microbiology
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RecordFirmDate
STAPHYLASE TEST (K874303)Oxoid U.S.A., Inc.1987-11-06
SERO-STAT R II STAPHYLOCOCCUS TEST (K863025)Scott Laboratories, Inc.1986-09-15
ENDO-STAPH TEICHOIC ACID ANTIBODY KIT (K820531)Meridian Diagnostics, Inc.1982-04-14
STAPHYLOCOCCUS LATEX AGGLUTINATION KIT (K820683)American Scientific Products1982-04-14
ACCU-STAPH (K820347)Carr-Scarborough Microbiologicals, Inc.1982-03-04
DIAGNOSTIC KITS & KIT COMPONENTS (K812434)Diagnostica, Inc.1981-09-23
RAT BLOOD IN ALSEVER'S, CITRATED (K812368)Dutchland Laboratories, Inc.1981-09-09
ADULT CHICKEN BLOOD IN ALSEVER'S, C., D. (K812374)Dutchland Laboratories, Inc.1981-09-09
SHEEP BLOOD IN ALSEVER'S, CITR., DEFIBR (K812376)Dutchland Laboratories, Inc.1981-09-09
GOOSE BLOOD IN ALSEVER'S, CITRATED (ACD) (K812367)Dutchland Laboratories, Inc.1981-09-09
RABBIT BLOOD IN ALSEVER'S, CITR., DEFIBR (K812373)Dutchland Laboratories, Inc.1981-09-09
BABY CHICK BLOOD IN ALSEVER'S (K812375)Dutchland Laboratories, Inc.1981-09-09
GUINEA PIG BLOOD IN ALSEVER'S, CIT., DEF (K812372)Dutchland Laboratories, Inc.1981-09-09

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